7,969 Clinical Trial Coordinators jobs in the United States

Senior Executive - clinical trial management

07024 Fort Lee, New Jersey Mezzion Pharma Co. Ltd

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This is a full-time, on-site role for a Senior Executive - Clinical Trial Management located in Fort Lee, NJ. The Senior Executive will oversee day-to-day clinical trial activities, ensure compliance with regulatory requirements, and coordinate with various stakeholders including CROs, investigators, and internal teams. This role involves developing and implementing clinical trial protocols, monitoring trial progress, and managing budgets and timelines. The Senior Executive will also be responsible for data analysis, report generation, and ensuring quality control throughout the trial process.

Qualifications
  • Experience with clinical trial management, protocol development, and implementation
  • Understanding of regulatory requirements and compliance in the clinical trial domain
  • Project management skills, including budget and timeline management
  • Ability to analyze clinical trial data and generate reports
  • Excellent communication and coordination skills to work with CROs, investigators, and internal teams
  • Strong problem-solving skills and attention to detail
  • Advanced degree in life sciences, pharmacy, or other related fields is preferred
  • Previous experience in the pharmaceutical industry is beneficial
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FSP Clinical Trial Coordinator

32616 Lake City, Florida ThermoFisher Scientific

Posted 2 days ago

Job Viewed

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Discover Impactful Work:**
The **Clinical Trial Coordinator** provides administrative and technical support to the Project Team. Candidates must hold 1-2 years of clinical trials-related experience and be familiar with Veeva Vault (CDMS and CTMS) with proven ability to manage meeting agendas and minutes. They must also demonstrate proficiency in maintaining study team rosters, understanding the importance of TMF quality control for inspection readiness, and effectively monitoring site reports while addressing concerns with the CSM. Additionally, experience in maintaining an organized list of Standard Operating Procedures (SOPs) is essential.
Those candidates with vendor budget/invoice tracking experience and familiarity with systems to check enrollment, timelines, and run metric reports among other duties are a significant plus.
**Education**
Bachelor's degree preferred. In some cases, additional vocational qualifications may be considered in lieu of a degree.
**Experience**
Previous experience that provides the knowledge, skills, and abilities to perform the job ( **at least 1year** ). Strong experience in CTMS systems and eTMF systems (specifically Veeva Vault).
**A day in the Life:**
+ Coordinates, oversees and completes functions on assigned trial(s) activities.
+ Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Proactively communicates any risks to project leads and line manager as appropriate.
+ Performs administrative tasks on assigned trials including but not limited to timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
+ Reviews and tracks local regulatory documents. Maintains vendor trackers.
+ Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
+ Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
+ Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
+ Trains new personnel in processes and systems.
+ Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).
+ May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
+ May assist with start-up activities and support start-up team in Regulatory submissions.
+ Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
+ May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites.
**Knowledge, Skills, Abilities**
+ Strong organizational skills and attention to detail, with proven track record to handle multiple tasks efficiently and effectively
+ Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
+ Strong customer focus
+ Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
+ Good presentation skills
+ Excellent digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
+ Self-motivated, positive attitude with effective strong interpersonal skills
+ Effective oral and written English communication skills, with the ability to communicate effectively with medical personnel
+ Excellent interpersonal skills
+ Strong attention to detail and quality of documentation
+ Good digital literacy and the ability to learn appropriate software
+ Basic medical/therapeutic area and medical terminology knowledge
+ Ability to work in a team environment or independently.
+ Ability to attain and maintain a solid understanding of GCP and applicable SOPs
+ Proven flexibility and adaptability
+ A proven relationship builder
+ Ability to manage risk and perform risk escalation appropriately
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Work is performed in a home office environment with exposure to electrical office equipment.
**Physical Requirements:**
+ Frequently stationary for 4-6 hours per day.
+ Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
+ Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
+ Ability to communicate so others will understand; with the ability to listen to and understand information and ideas.
+ May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
+ Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
+ Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
The salary range estimated for this position is $20.00 hourly - $3.00 hourly, dependent on leveling. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.
We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
+ A choice of national medical and dental plans, and a national vision plan
+ A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)
+ Tax-advantaged savings and spending accounts and commuter benefits
+ Employee assistance program
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability** **Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
**Compensation and Benefits**
The hourly pay range estimated for this position Clin Ops Delivery Associate I based inNorth Carolina is 45,000.00- 47,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
View Now

FSP Clinical Trial Coordinator

21705 Frederick, Maryland ThermoFisher Scientific

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Discover Impactful Work:**
The **Clinical Trial Coordinator** provides administrative and technical support to the Project Team. Candidates must hold 1-2 years of clinical trials-related experience and be familiar with Veeva Vault (CDMS and CTMS) with proven ability to manage meeting agendas and minutes. They must also demonstrate proficiency in maintaining study team rosters, understanding the importance of TMF quality control for inspection readiness, and effectively monitoring site reports while addressing concerns with the CSM. Additionally, experience in maintaining an organized list of Standard Operating Procedures (SOPs) is essential.
Those candidates with vendor budget/invoice tracking experience and familiarity with systems to check enrollment, timelines, and run metric reports among other duties are a significant plus.
**Education**
Bachelor's degree preferred. In some cases, additional vocational qualifications may be considered in lieu of a degree.
**Experience**
Previous experience that provides the knowledge, skills, and abilities to perform the job ( **at least 1year** ). Strong experience in CTMS systems and eTMF systems (specifically Veeva Vault).
**A day in the Life:**
+ Coordinates, oversees and completes functions on assigned trial(s) activities.
+ Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Proactively communicates any risks to project leads and line manager as appropriate.
+ Performs administrative tasks on assigned trials including but not limited to timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
+ Reviews and tracks local regulatory documents. Maintains vendor trackers.
+ Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
+ Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
+ Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
+ Trains new personnel in processes and systems.
+ Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).
+ May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
+ May assist with start-up activities and support start-up team in Regulatory submissions.
+ Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
+ May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites.
**Knowledge, Skills, Abilities**
+ Strong organizational skills and attention to detail, with proven track record to handle multiple tasks efficiently and effectively
+ Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
+ Strong customer focus
+ Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
+ Good presentation skills
+ Excellent digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
+ Self-motivated, positive attitude with effective strong interpersonal skills
+ Effective oral and written English communication skills, with the ability to communicate effectively with medical personnel
+ Excellent interpersonal skills
+ Strong attention to detail and quality of documentation
+ Good digital literacy and the ability to learn appropriate software
+ Basic medical/therapeutic area and medical terminology knowledge
+ Ability to work in a team environment or independently.
+ Ability to attain and maintain a solid understanding of GCP and applicable SOPs
+ Proven flexibility and adaptability
+ A proven relationship builder
+ Ability to manage risk and perform risk escalation appropriately
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Work is performed in a home office environment with exposure to electrical office equipment.
**Physical Requirements:**
+ Frequently stationary for 4-6 hours per day.
+ Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
+ Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
+ Ability to communicate so others will understand; with the ability to listen to and understand information and ideas.
+ May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
+ Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
+ Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
The salary range estimated for this position is $20.00 hourly - $3.00 hourly, dependent on leveling. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.
We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
+ A choice of national medical and dental plans, and a national vision plan
+ A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)
+ Tax-advantaged savings and spending accounts and commuter benefits
+ Employee assistance program
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability** **Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
**Compensation and Benefits**
The hourly pay range estimated for this position Clin Ops Delivery Associate I based inNorth Carolina is 45,000.00- 47,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
View Now

FSP Clinical Trial Coordinator

28407 Marshville, North Carolina ThermoFisher Scientific

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Discover Impactful Work:**
The **Clinical Trial Coordinator** provides administrative and technical support to the Project Team. Candidates must hold 1-2 years of clinical trials-related experience and be familiar with Veeva Vault (CDMS and CTMS) with proven ability to manage meeting agendas and minutes. They must also demonstrate proficiency in maintaining study team rosters, understanding the importance of TMF quality control for inspection readiness, and effectively monitoring site reports while addressing concerns with the CSM. Additionally, experience in maintaining an organized list of Standard Operating Procedures (SOPs) is essential.
Those candidates with vendor budget/invoice tracking experience and familiarity with systems to check enrollment, timelines, and run metric reports among other duties are a significant plus.
**Education**
Bachelor's degree preferred. In some cases, additional vocational qualifications may be considered in lieu of a degree.
**Experience**
Previous experience that provides the knowledge, skills, and abilities to perform the job ( **at least 1year** ). Strong experience in CTMS systems and eTMF systems (specifically Veeva Vault).
**A day in the Life:**
+ Coordinates, oversees and completes functions on assigned trial(s) activities.
+ Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Proactively communicates any risks to project leads and line manager as appropriate.
+ Performs administrative tasks on assigned trials including but not limited to timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
+ Reviews and tracks local regulatory documents. Maintains vendor trackers.
+ Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
+ Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
+ Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
+ Trains new personnel in processes and systems.
+ Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).
+ May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
+ May assist with start-up activities and support start-up team in Regulatory submissions.
+ Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
+ May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites.
**Knowledge, Skills, Abilities**
+ Strong organizational skills and attention to detail, with proven track record to handle multiple tasks efficiently and effectively
+ Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
+ Strong customer focus
+ Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
+ Good presentation skills
+ Excellent digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
+ Self-motivated, positive attitude with effective strong interpersonal skills
+ Effective oral and written English communication skills, with the ability to communicate effectively with medical personnel
+ Excellent interpersonal skills
+ Strong attention to detail and quality of documentation
+ Good digital literacy and the ability to learn appropriate software
+ Basic medical/therapeutic area and medical terminology knowledge
+ Ability to work in a team environment or independently.
+ Ability to attain and maintain a solid understanding of GCP and applicable SOPs
+ Proven flexibility and adaptability
+ A proven relationship builder
+ Ability to manage risk and perform risk escalation appropriately
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Work is performed in a home office environment with exposure to electrical office equipment.
**Physical Requirements:**
+ Frequently stationary for 4-6 hours per day.
+ Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
+ Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
+ Ability to communicate so others will understand; with the ability to listen to and understand information and ideas.
+ May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
+ Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
+ Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
The salary range estimated for this position is $20.00 hourly - $3.00 hourly, dependent on leveling. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.
We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
+ A choice of national medical and dental plans, and a national vision plan
+ A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)
+ Tax-advantaged savings and spending accounts and commuter benefits
+ Employee assistance program
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability** **Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
**Compensation and Benefits**
The hourly pay range estimated for this position Clin Ops Delivery Associate I based inNorth Carolina is 45,000.00- 47,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
View Now

FSP Clinical Trial Coordinator

27835 Greenville, North Carolina ThermoFisher Scientific

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Discover Impactful Work:**
The **Clinical Trial Coordinator** provides administrative and technical support to the Project Team. Candidates must hold 1-2 years of clinical trials-related experience and be familiar with Veeva Vault (CDMS and CTMS) with proven ability to manage meeting agendas and minutes. They must also demonstrate proficiency in maintaining study team rosters, understanding the importance of TMF quality control for inspection readiness, and effectively monitoring site reports while addressing concerns with the CSM. Additionally, experience in maintaining an organized list of Standard Operating Procedures (SOPs) is essential.
Those candidates with vendor budget/invoice tracking experience and familiarity with systems to check enrollment, timelines, and run metric reports among other duties are a significant plus.
**Education**
Bachelor's degree preferred. In some cases, additional vocational qualifications may be considered in lieu of a degree.
**Experience**
Previous experience that provides the knowledge, skills, and abilities to perform the job ( **at least 1year** ). Strong experience in CTMS systems and eTMF systems (specifically Veeva Vault).
**A day in the Life:**
+ Coordinates, oversees and completes functions on assigned trial(s) activities.
+ Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Proactively communicates any risks to project leads and line manager as appropriate.
+ Performs administrative tasks on assigned trials including but not limited to timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
+ Reviews and tracks local regulatory documents. Maintains vendor trackers.
+ Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
+ Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
+ Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
+ Trains new personnel in processes and systems.
+ Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).
+ May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
+ May assist with start-up activities and support start-up team in Regulatory submissions.
+ Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
+ May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites.
**Knowledge, Skills, Abilities**
+ Strong organizational skills and attention to detail, with proven track record to handle multiple tasks efficiently and effectively
+ Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
+ Strong customer focus
+ Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
+ Good presentation skills
+ Excellent digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
+ Self-motivated, positive attitude with effective strong interpersonal skills
+ Effective oral and written English communication skills, with the ability to communicate effectively with medical personnel
+ Excellent interpersonal skills
+ Strong attention to detail and quality of documentation
+ Good digital literacy and the ability to learn appropriate software
+ Basic medical/therapeutic area and medical terminology knowledge
+ Ability to work in a team environment or independently.
+ Ability to attain and maintain a solid understanding of GCP and applicable SOPs
+ Proven flexibility and adaptability
+ A proven relationship builder
+ Ability to manage risk and perform risk escalation appropriately
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Work is performed in a home office environment with exposure to electrical office equipment.
**Physical Requirements:**
+ Frequently stationary for 4-6 hours per day.
+ Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
+ Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
+ Ability to communicate so others will understand; with the ability to listen to and understand information and ideas.
+ May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
+ Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
+ Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
The salary range estimated for this position is $20.00 hourly - $3.00 hourly, dependent on leveling. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.
We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
+ A choice of national medical and dental plans, and a national vision plan
+ A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)
+ Tax-advantaged savings and spending accounts and commuter benefits
+ Employee assistance program
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability** **Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
**Compensation and Benefits**
The hourly pay range estimated for this position Clin Ops Delivery Associate I based inNorth Carolina is 45,000.00- 47,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
View Now

FSP Clinical Trial Coordinator

23274 Richmond, Virginia ThermoFisher Scientific

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Discover Impactful Work:**
The **Clinical Trial Coordinator** provides administrative and technical support to the Project Team. Candidates must hold 1-2 years of clinical trials-related experience and be familiar with Veeva Vault (CDMS and CTMS) with proven ability to manage meeting agendas and minutes. They must also demonstrate proficiency in maintaining study team rosters, understanding the importance of TMF quality control for inspection readiness, and effectively monitoring site reports while addressing concerns with the CSM. Additionally, experience in maintaining an organized list of Standard Operating Procedures (SOPs) is essential.
Those candidates with vendor budget/invoice tracking experience and familiarity with systems to check enrollment, timelines, and run metric reports among other duties are a significant plus.
**Education**
Bachelor's degree preferred. In some cases, additional vocational qualifications may be considered in lieu of a degree.
**Experience**
Previous experience that provides the knowledge, skills, and abilities to perform the job ( **at least 1year** ). Strong experience in CTMS systems and eTMF systems (specifically Veeva Vault).
**A day in the Life:**
+ Coordinates, oversees and completes functions on assigned trial(s) activities.
+ Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Proactively communicates any risks to project leads and line manager as appropriate.
+ Performs administrative tasks on assigned trials including but not limited to timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
+ Reviews and tracks local regulatory documents. Maintains vendor trackers.
+ Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
+ Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
+ Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
+ Trains new personnel in processes and systems.
+ Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).
+ May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
+ May assist with start-up activities and support start-up team in Regulatory submissions.
+ Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
+ May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites.
**Knowledge, Skills, Abilities**
+ Strong organizational skills and attention to detail, with proven track record to handle multiple tasks efficiently and effectively
+ Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
+ Strong customer focus
+ Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
+ Good presentation skills
+ Excellent digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
+ Self-motivated, positive attitude with effective strong interpersonal skills
+ Effective oral and written English communication skills, with the ability to communicate effectively with medical personnel
+ Excellent interpersonal skills
+ Strong attention to detail and quality of documentation
+ Good digital literacy and the ability to learn appropriate software
+ Basic medical/therapeutic area and medical terminology knowledge
+ Ability to work in a team environment or independently.
+ Ability to attain and maintain a solid understanding of GCP and applicable SOPs
+ Proven flexibility and adaptability
+ A proven relationship builder
+ Ability to manage risk and perform risk escalation appropriately
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Work is performed in a home office environment with exposure to electrical office equipment.
**Physical Requirements:**
+ Frequently stationary for 4-6 hours per day.
+ Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
+ Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
+ Ability to communicate so others will understand; with the ability to listen to and understand information and ideas.
+ May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
+ Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
+ Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
The salary range estimated for this position is $20.00 hourly - $3.00 hourly, dependent on leveling. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.
We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
+ A choice of national medical and dental plans, and a national vision plan
+ A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)
+ Tax-advantaged savings and spending accounts and commuter benefits
+ Employee assistance program
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability** **Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
**Compensation and Benefits**
The hourly pay range estimated for this position Clin Ops Delivery Associate I based inNorth Carolina is 45,000.00- 47,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
View Now

FSP Clinical Trial Coordinator

15222 Pittsburgh, Pennsylvania ThermoFisher Scientific

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Discover Impactful Work:**
The **Clinical Trial Coordinator** provides administrative and technical support to the Project Team. Candidates must hold 1-2 years of clinical trials-related experience and be familiar with Veeva Vault (CDMS and CTMS) with proven ability to manage meeting agendas and minutes. They must also demonstrate proficiency in maintaining study team rosters, understanding the importance of TMF quality control for inspection readiness, and effectively monitoring site reports while addressing concerns with the CSM. Additionally, experience in maintaining an organized list of Standard Operating Procedures (SOPs) is essential.
Those candidates with vendor budget/invoice tracking experience and familiarity with systems to check enrollment, timelines, and run metric reports among other duties are a significant plus.
**Education**
Bachelor's degree preferred. In some cases, additional vocational qualifications may be considered in lieu of a degree.
**Experience**
Previous experience that provides the knowledge, skills, and abilities to perform the job ( **at least 1year** ). Strong experience in CTMS systems and eTMF systems (specifically Veeva Vault).
**A day in the Life:**
+ Coordinates, oversees and completes functions on assigned trial(s) activities.
+ Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Proactively communicates any risks to project leads and line manager as appropriate.
+ Performs administrative tasks on assigned trials including but not limited to timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
+ Reviews and tracks local regulatory documents. Maintains vendor trackers.
+ Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
+ Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
+ Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
+ Trains new personnel in processes and systems.
+ Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).
+ May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
+ May assist with start-up activities and support start-up team in Regulatory submissions.
+ Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
+ May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites.
**Knowledge, Skills, Abilities**
+ Strong organizational skills and attention to detail, with proven track record to handle multiple tasks efficiently and effectively
+ Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
+ Strong customer focus
+ Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
+ Good presentation skills
+ Excellent digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
+ Self-motivated, positive attitude with effective strong interpersonal skills
+ Effective oral and written English communication skills, with the ability to communicate effectively with medical personnel
+ Excellent interpersonal skills
+ Strong attention to detail and quality of documentation
+ Good digital literacy and the ability to learn appropriate software
+ Basic medical/therapeutic area and medical terminology knowledge
+ Ability to work in a team environment or independently.
+ Ability to attain and maintain a solid understanding of GCP and applicable SOPs
+ Proven flexibility and adaptability
+ A proven relationship builder
+ Ability to manage risk and perform risk escalation appropriately
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Work is performed in a home office environment with exposure to electrical office equipment.
**Physical Requirements:**
+ Frequently stationary for 4-6 hours per day.
+ Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
+ Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
+ Ability to communicate so others will understand; with the ability to listen to and understand information and ideas.
+ May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
+ Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
+ Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
The salary range estimated for this position is $20.00 hourly - $3.00 hourly, dependent on leveling. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.
We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
+ A choice of national medical and dental plans, and a national vision plan
+ A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)
+ Tax-advantaged savings and spending accounts and commuter benefits
+ Employee assistance program
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability** **Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
**Compensation and Benefits**
The hourly pay range estimated for this position Clin Ops Delivery Associate I based inNorth Carolina is 45,000.00- 47,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
View Now
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About the latest Clinical trial coordinators Jobs in United States !

FSP Clinical Trial Coordinator

18103 Allentown, Pennsylvania ThermoFisher Scientific

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Discover Impactful Work:**
The **Clinical Trial Coordinator** provides administrative and technical support to the Project Team. Candidates must hold 1-2 years of clinical trials-related experience and be familiar with Veeva Vault (CDMS and CTMS) with proven ability to manage meeting agendas and minutes. They must also demonstrate proficiency in maintaining study team rosters, understanding the importance of TMF quality control for inspection readiness, and effectively monitoring site reports while addressing concerns with the CSM. Additionally, experience in maintaining an organized list of Standard Operating Procedures (SOPs) is essential.
Those candidates with vendor budget/invoice tracking experience and familiarity with systems to check enrollment, timelines, and run metric reports among other duties are a significant plus.
**Education**
Bachelor's degree preferred. In some cases, additional vocational qualifications may be considered in lieu of a degree.
**Experience**
Previous experience that provides the knowledge, skills, and abilities to perform the job ( **at least 1year** ). Strong experience in CTMS systems and eTMF systems (specifically Veeva Vault).
**A day in the Life:**
+ Coordinates, oversees and completes functions on assigned trial(s) activities.
+ Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Proactively communicates any risks to project leads and line manager as appropriate.
+ Performs administrative tasks on assigned trials including but not limited to timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
+ Reviews and tracks local regulatory documents. Maintains vendor trackers.
+ Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
+ Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
+ Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
+ Trains new personnel in processes and systems.
+ Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).
+ May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
+ May assist with start-up activities and support start-up team in Regulatory submissions.
+ Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
+ May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites.
**Knowledge, Skills, Abilities**
+ Strong organizational skills and attention to detail, with proven track record to handle multiple tasks efficiently and effectively
+ Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
+ Strong customer focus
+ Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
+ Good presentation skills
+ Excellent digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
+ Self-motivated, positive attitude with effective strong interpersonal skills
+ Effective oral and written English communication skills, with the ability to communicate effectively with medical personnel
+ Excellent interpersonal skills
+ Strong attention to detail and quality of documentation
+ Good digital literacy and the ability to learn appropriate software
+ Basic medical/therapeutic area and medical terminology knowledge
+ Ability to work in a team environment or independently.
+ Ability to attain and maintain a solid understanding of GCP and applicable SOPs
+ Proven flexibility and adaptability
+ A proven relationship builder
+ Ability to manage risk and perform risk escalation appropriately
**Physical Requirements / Work Environment**
Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
+ Work is performed in a home office environment with exposure to electrical office equipment.
**Physical Requirements:**
+ Frequently stationary for 4-6 hours per day.
+ Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
+ Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
+ Ability to communicate so others will understand; with the ability to listen to and understand information and ideas.
+ May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
+ Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
+ Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
The salary range estimated for this position is $20.00 hourly - $3.00 hourly, dependent on leveling. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.
We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
+ A choice of national medical and dental plans, and a national vision plan
+ A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)
+ Tax-advantaged savings and spending accounts and commuter benefits
+ Employee assistance program
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today!** ** Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability** **Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
**Compensation and Benefits**
The hourly pay range estimated for this position Clin Ops Delivery Associate I based inNorth Carolina is 45,000.00- 47,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
View Now

Manager Clinical Trial Project Management

19477 Spring House, Pennsylvania J&J Family of Companies

Posted 6 days ago

Job Viewed

Tap Again To Close

Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
R&D Operations
**Job Sub** **Function:**
Clinical Trial Project Management
**Job Category:**
Professional
**All Job Posting Locations:**
Spring House, Pennsylvania, United States of America
**Job Description:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a **Manager, Clinical Trial Project Management** to be responsible for the creation and management of a subset of studies within our Medical Affairs Deliver Unit Portfolio. You will collect, consolidate, and report budget, timeline and FTE actuals vs. plan and will identify potential issues for the trial through active management of the study schedule. The position may be located **Beerse, Belgium; Leiden, Netherlands; Madrid, Spain; High Wycombe, UK; Cork, Ireland; Warsaw, Poland; or Spring House, United States.** The position is Hybrid (3 days onsite weekly).
**You will be responsible for:**
+ Creating, managing, and maintaining study schedules in PLW + For company sponsored and collaborative studies; creating initial study costing and support initial OOPS management up till FPI.
+ Assuring Clinical timelines in PLW align to mCTMS and to latest assumptions. Ensuring proper resource demand is reflected
+ Developing scenarios in PLW for budget, timeline, and FTE forecasting, while generating situational operational scenarios.
+ Collecting, consolidating, and reporting financial, timeline and resource data for governance approvals and external funding partnerships. Managing scope control, FTE and OOP variances. + Providing necessary Portfolio Data Insights to the TA leads
+ Providing necessary Portfolio Data Insights to the TA leads
+ Providing support to Finance, Business Partners and Commercial Stakeholders
**Additional Responsibilities may Include:**
+ Mentoring and supporting onboarding of new team members, particularly those in Trial Management.
+ Fostering employee engagement, inclusion, and Credo Behaviors.
**Principal Relationships:**
Internal: Trial Delivery Leader, Trial Delivery Manager, Program Delivery Leaders, Clinical Trial Assistants, DAS Leaders, Trial Management Directors, representatives of Delivery Operations, representatives of other GD and non-GD Functions and Clinical and Project Management Teams
**Qualifications /Requirements:**
+ BS degree or equivalent, preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
+ Minimum of 6 years of experience in Pharmaceutical, Healthcare or related industries.
+ Experience in and knowledge of the pharmaceutical development process
+ Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage all aspects of execution of a clinical trial.
+ Experience in Project Management, preferably within Research & Development.
+ Knowledge of Project Management Systems, Methodologies & Tools.
+ Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness. Experience of leading without authority and in muti-functional matrixed and global environments. Excellent decision-making, analytical and strong financial management skills are essential to this position. Operates and executes with limited supervision. Experience mentoring/coaching others.
+ Strong project planning/management, communication and presentation skills are required.
+ Travel up to 10% of the time, defined by business needs.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
+ Belgium, Ireland, Netherlands, Spain, Poland- Requisition Number: R-
+ United Kingdom - Requisition Number: R-
+ United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants only:**
The anticipated base pay range for this position is $115,000 to $197,800 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
**#LI-Hybrid**
**The anticipated base pay range for this position is :**
115,000 - 197,800 USD
Additional Description for Pay Transparency:
View Now

Manager Clinical Trial Project Management

19477 Spring House, Pennsylvania Johnson and Johnson

Posted 7 days ago

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Job Description

Permanent

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a Manager, Clinical Trial Project Management to be responsible for the creation and management of a subset of studies within our Medical Affairs Deliver Unit Portfolio. You will collect, consolidate, and report budget, timeline and FTE actuals vs. plan and will identify potential issues for the trial through active management of the study schedule. The position may be located Beerse, Belgium; Leiden, Netherlands; Madrid, Spain; High Wycombe, UK; Cork, Ireland; Warsaw, Poland; or Spring House, United States. The position is Hybrid (3 days onsite weekly).

You will be responsible for:

  • Creating, managing, and maintaining study schedules in PLW + For company sponsored and collaborative studies; creating initial study costing and support initial OOPS management up till FPI.
  • Assuring Clinical timelines in PLW align to mCTMS and to latest assumptions. Ensuring proper resource demand is reflected
  • Developing scenarios in PLW for budget, timeline, and FTE forecasting, while generating situational operational scenarios.
  • Collecting, consolidating, and reporting financial, timeline and resource data for governance approvals and external funding partnerships. Managing scope control, FTE and OOP variances. + Providing necessary Portfolio Data Insights to the TA leads
  • Providing necessary Portfolio Data Insights to the TA leads
  • Providing support to Finance, Business Partners and Commercial Stakeholders

Additional Responsibilities may Include:

  • Mentoring and supporting onboarding of new team members, particularly those in Trial Management.
  • Fostering employee engagement, inclusion, and Credo Behaviors.

Principal Relationships:

Internal: Trial Delivery Leader, Trial Delivery Manager, Program Delivery Leaders, Clinical Trial Assistants, DAS Leaders, Trial Management Directors, representatives of Delivery Operations, representatives of other GD and non-GD Functions and Clinical and Project Management Teams

Qualifications /Requirements:

  • BS degree or equivalent, preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
  • Minimum of 6 years of experience in Pharmaceutical, Healthcare or related industries.
  • Experience in and knowledge of the pharmaceutical development process
  • Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage all aspects of execution of a clinical trial.
  • Experience in Project Management, preferably within Research & Development.
  • Knowledge of Project Management Systems, Methodologies & Tools.
  • Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness. Experience of leading without authority and in muti-functional matrixed and global environments. Excellent decision-making, analytical and strong financial management skills are essential to this position. Operates and executes with limited supervision. Experience mentoring/coaching others.
  • Strong project planning/management, communication and presentation skills are required.
  • Travel up to 10% of the time, defined by business needs.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

  • Belgium, Ireland, Netherlands, Spain, Poland- Requisition Number: R-
  • United Kingdom - Requisition Number: R-
  • United States - Requisition Number: R-

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

For United States applicants only: 

The anticipated base pay range for this position is $115,000 to $197,800 (USD).  

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.  

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.  

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).  

Employees are eligible for the following time off benefits: 

- Vacation - up to 120 hours per calendar year  

  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year 

- Holiday pay, including Floating Holidays - up to 13 days per calendar year  

- Work, Personal and Family Time - up to 40 hours per calendar year  

For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.  

#LI-Hybrid

The anticipated base pay range for this position is :

115,000 - 197,800 USD

Additional Description for Pay Transparency:

Apply Now
 

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