7 Clinical Development Director jobs in Star
Senior Director, Global Clinical Development CNS
Posted 7 days ago
Job Viewed
Job Description
Position Summary
The purpose of this position is to lead the clinical development activities in support of domestic and international clinical development initiatives.
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA and/or Global filings.
Key Job Responsibilities
-
Conceives, implements, and analyzes drug development programs, including:
-
Understanding pharmacology of drugs and unmet medical needs.
-
Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy.
-
Working with experts and consultants in the field to refine a clinical development strategy.
-
Designing clinical trials for the purpose of meeting specific objectives.
-
Anticipating and addressing future commercial and clinical development needs, based on the clinicalcharacter of the compound.
-
Implements clinical development programs, including:
-
Co-authoring global clinical development plans with all practical elements.
-
Leading and motivating the clinical development team to operationalize the clinical develop strategy,i.e., clinical trials management.
-
Partnering with internal and external clinical experts and consultants to optimize the scientific integrity of the methodology and ensure the safety of clinical subjects.
-
Leading clinical trial projects to ensure all aspects of the clinical trial project plan (e.g., enrollment, database lock) are achieved on time and with the highest quality.
-
Developing and leading formal presentations of results to the medical community, in written, verbal, andvisual formats.
-
Analyzes and interprets the results of clinical programs in collaboration with clinical, biometric and clinical pharmacology experts.
-
Partners with biostatistics, medical writers, and external consultants to understand and present the results ofclinical development programs.
-
Partners with internal decision makers to evaluate critical decision points.
-
Acts as a signatory for the medical monitoring team.
-
Contributes to corporate initiatives by participating in continuous process improvement to meet companyobjectives as well as evaluates in-licensing opportunities and/or additional life cycle management opportunities.
-
Participates in NDA development, submission and defense.
-
Lectures at national and international meetings, scientific advisory board meetings, and data safety monitoring boards.
-
Mentors junior team members.
Knowledge, Skills, Competencies, Education, and Experience
Required:
-
A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. Board certification in Psychiatry and Neurology is highly desired. Minimum of five years of clinical research experience (post Academia).
-
Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
-
An advanced understanding of clinical medicine and science.
-
Advanced understanding of drug development principles and clinical trial implementation and management.
-
Complete understanding of the global regulatory requirements.
-
Working knowledge of marketing and commercialization.
-
Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
-
Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
-
Demonstrated experience in leading a successful regulatory filing.
-
Ability to work across different therapeutic areas and different stages of clinical development.
-
Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
-
Strong communication and presentation skills.
-
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
-
Knows how/when to apply organizational policy or procedures to a variety of situations.
Physical Demands and Work Environment
Travel (approximately 30 % )
See document Physical Demands and Work Environment for further requirements.
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
Company benefits : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; .
Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ( ) .
Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: . If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Global Clinical Development CNS
Posted today
Job Viewed
Job Description
The purpose of this position is to lead the clinical development activities in support of domestic and international clinical development initiatives.
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA and/or Global filings.
**Key Job Responsibilities**
+ Conceives, implements, and analyzes drug development programs, including:
+ Understanding pharmacology of drugs and unmet medical needs.
+ Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy.
+ Working with experts and consultants in the field to refine a clinical development strategy.
+ Designing clinical trials for the purpose of meeting specific objectives.
+ Anticipating and addressing future commercial and clinical development needs, based on the clinicalcharacter of the compound.
+ Implements clinical development programs, including:
+ Co-authoring global clinical development plans with all practical elements.
+ Leading and motivating the clinical development team to operationalize the clinical develop strategy,i.e., clinical trials management.
+ Partnering with internal and external clinical experts and consultants to optimize the scientific integrity of the methodology and ensure the safety of clinical subjects.
+ Leading clinical trial projects to ensure all aspects of the clinical trial project plan (e.g., enrollment, database lock) are achieved on time and with the highest quality.
+ Developing and leading formal presentations of results to the medical community, in written, verbal, andvisual formats.
+ Analyzes and interprets the results of clinical programs in collaboration with clinical, biometric and clinical pharmacology experts.
+ Partners with biostatistics, medical writers, and external consultants to understand and present the results ofclinical development programs.
+ Partners with internal decision makers to evaluate critical decision points.
+ Acts as a signatory for the medical monitoring team.
+ Contributes to corporate initiatives by participating in continuous process improvement to meet companyobjectives as well as evaluates in-licensing opportunities and/or additional life cycle management opportunities.
+ Participates in NDA development, submission and defense.
+ Lectures at national and international meetings, scientific advisory board meetings, and data safety monitoring boards.
+ Mentors junior team members.
**Knowledge, Skills, Competencies, Education, and Experience**
Required:
+ A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. Board certification in Psychiatry and Neurology is highly desired. Minimum of five years of clinical research experience (post Academia).
+ Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
+ An advanced understanding of clinical medicine and science.
+ Advanced understanding of drug development principles and clinical trial implementation and management.
+ Complete understanding of the global regulatory requirements.
+ Working knowledge of marketing and commercialization.
+ Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
+ Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
+ Demonstrated experience in leading a successful regulatory filing.
+ Ability to work across different therapeutic areas and different stages of clinical development.
+ Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
+ Strong communication and presentation skills.
+ Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
+ Knows how/when to apply organizational policy or procedures to a variety of situations.
**Physical Demands and Work Environment**
Travel (approximately 30 **%** )
See document Physical Demands and Work Environment for further requirements.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
**Company benefits** : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request ( ) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: . If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Clinical Research Coordinator
Posted today
Job Viewed
Job Description
Our patients come from all walks of life and so do we! We foster an environment that embraces our employees' unique strengths, experiences and perspectives which drive our exceptional patient-centered care. We strive to build a positive, supportive, and inclusive culture to deliver exceptional patient experiences and create a strong work environment.
Children and Adult Specialty Research encompasses a variety of indications, including adult and pediatric trials for endocrine diseases, cystic fibrosis (CF), and pulmonary diseases in both outpatient and inpatient settings. The primary focus of this position is the coordination of pulmonology inpatient treatment trials. The candidate must be available for occasional weekend hours, depending on the study and enrollment quantity, and should be flexible to work between inpatient (both floor and ICU) and outpatient clinical trials. A successful candidate will be someone who craves variety in their work and wants to integrate and collaborate with team members across multiple studies within the department.
Conducts and documents informed consent process. Reviews clinical records and extracts necessary data to determine eligibility and complete data submission via the appropriate mechanism. Assists in recruiting patients for clinical trials. Conducts research activities per protocol. Documents research process, adverse event grading, consent process, patient progress on study in electronic medical record. Initiates and submits Serious Adverse Events reports to study sponsor in collaboration with the physician and/or principal investigator. Maintains clinical trials management system; prepare reports as needed. Prepares for and conducts study monitor visits and audits. Serves as liaison and reference to physicians, investigators and other staff members for questions regarding the research process. Collaborates with investigator and regulatory staff regarding Institutional Review Board requirements. Participates in protocol design, development, and writing, as well as writing study manuscripts. May complete scientific literature searches and due diligence practices prior to study inception. Prepares basic statistical reports or other reports and presentations as required. Collaborates with external community, business and academic partners. Works constructively with coworkers and clinicians to improve processes and standards of practice. Perform other duties and responsibilities as assigned.
Minimum Qualifications:
- Education: Bachelors degree.
- Experience: 3 years experience.
- Licenses/Certifications: Current Basic Life Support (BLS) Provider Certified through American Safety and Health Institute, American Heart Association, or American Red Cross.
Whats in it for you At St. Lukes, caring for people in the communities we serve is our mission and this includes our own SLHS team. We offer a robust benefits package to support our teams both professionally and personally. In addition to a competitive salary and retirement plans, we ensure our team feels supported in their benefits beyond the typical medical, dental, and vision offerings. We care about you and have fantastic financial and physical wellness options, such as: on-site massages, on-site counseling via our Employee Assistance Program, access to the Virgin Pulse Wellness tool, as well as other formal training and career development offerings to ensure you are meeting your career goals. St. Lukes is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other status or condition protected by law.
Clinical Research Coordinator
Posted today
Job Viewed
Job Description
At St. Luke's, we pride ourselves on fostering a workplace culture that values diversity, promotes collaboration, and prioritizes employee well-being. Our commitment to excellence in patient care extends to creating an environment where our team can thrive both personally and professionally. With opportunities for growth, competitive benefits, and a supportive community of colleagues, St. Luke's is truly a great place to work.
**What You Can Expect:**
St. Luke's Cancer Institute Research encompasses cancer care for adult and pediatric patients, as well as blood and bleeding disorders, in outpatient and inpatient settings. The primary focus of this position is the coordination of adult clinical trials. A successful candidate will be someone who craves variety in their work and wants to integrate and collaborate with team members across multiple departments on a large variety of clinical trials.
+ Conducts and documents informed consent process.
+ Reviews clinical records and extracts necessary data to determine eligibility and complete data submission via the appropriate mechanism.
+ Assists in recruiting patients for clinical trials.
+ Conducts research activities per protocol.
+ Documents research process, adverse event grading, consent process, patient progress on study in electronic medical record.
+ Initiates and submits Serious Adverse Events reports to study sponsor in collaboration with the physician and/or principal investigator.
+ Maintains clinical trials management system; prepare reports as needed.
+ Prepares for and conducts study monitor visits and audits.
+ Serves as liaison and reference to physicians, investigators, and other staff members for questions regarding the research process.
+ Collaborates with investigator and regulatory staff regarding Institutional Review Board requirements.
+ Prepares basic statistical reports or other reports and presentations as required.
+ Collaborates with external community, business, and academic partners.
+ Works constructively with coworkers and clinicians to improve processes and standards of practice.
+ Perform other duties and responsibilities as assigned.
**Minimum Qualifications:**
+ Education: Bachelor's degree
+ Experience: 2 years' experience
**Preferred Qualifications:**
+ Strong background in oncology or clinical research
+ Working knowledge of medical and scientific terminology
+ Experience working directly with patients
**What's in it for you**
At St. Luke's, caring for people in the communities we serve is our mission - and this includes our own SLHS team. We offer a robust benefits package to support our teams both professionally and personally. In addition to a competitive salary and retirement plans, we ensure our team feels supported in their benefits beyond the typical medical, dental, and vision offerings. We care about you and have fantastic financial and physical wellness options, such as: on-site massages, on-site counseling via our Employee Assistance Program, access to the Virgin Pulse Wellness tool, as well as other formal training and career development offerings to ensure you are meeting your career goals.
St. Luke's is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other status or condition protected by law.
*Please note: this posting is not reflective of all job duties and responsibilities and is intended to provide an overview to job seekers.
**Default: Location : City** _Boise_
**Category** _Research_
**Work Unit** _Research Administration St Lukes Cancer Institute_
**Position Type** _Full-Time_
**Work Schedule** _DAY_
**Requisition ID** _2025-96555_
**Default: Location : Location** _US-ID-Boise_
**Work Location : Name** _100 E Idaho St., Boise, SLCI Boise_
Posting Clinical Research Coordinator
Posted today
Job Viewed
Job Description
At St. Luke's, we pride ourselves on fostering a workplace culture that values diversity, promotes collaboration, and prioritizes employee well-being. Our commitment to excellence in patient care extends to creating an environment where our team can thrive both personally and professionally. With opportunities for growth, competitive benefits, and a supportive community of colleagues, St. Luke's is truly a great place to work.
What You Can Expect:
St. Luke's Cancer Institute Research encompasses cancer care for adult and pediatric patients, as well as blood and bleeding disorders, in outpatient and inpatient settings. The primary focus of this position is the coordination of adult clinical trials. A successful candidate will be someone who craves variety in their work and wants to integrate and collaborate with team members across multiple departments on a large variety of clinical trials.
- Conducts and documents informed consent process.
- Reviews clinical records and extracts necessary data to determine eligibility and complete data submission via the appropriate mechanism.
- Assists in recruiting patients for clinical trials.
- Conducts research activities per protocol.
- Documents research process, adverse event grading, consent process, patient progress on study in electronic medical record.
- Initiates and submits Serious Adverse Events reports to study sponsor in collaboration with the physician and/or principal investigator.
- Maintains clinical trials management system; prepare reports as needed.
- Prepares for and conducts study monitor visits and audits.
- Serves as liaison and reference to physicians, investigators, and other staff members for questions regarding the research process.
- Collaborates with investigator and regulatory staff regarding Institutional Review Board requirements.
- Prepares basic statistical reports or other reports and presentations as required.
- Collaborates with external community, business, and academic partners.
- Works constructively with coworkers and clinicians to improve processes and standards of practice.
- Perform other duties and responsibilities as assigned.
Minimum Qualifications:
- Education: Bachelor's degree
- Experience: 2 years' experience
Preferred Qualifications:
- Strong background in oncology or clinical research
- Working knowledge of medical and scientific terminology
- Experience working directly with patients
At St. Luke's, caring for people in the communities we serve is our mission and this includes our own SLHS team. We offer a robust benefits package to support our teams both professionally and personally. In addition to a competitive salary and retirement plans, we ensure our team feels supported in their benefits beyond the typical medical, dental, and vision offerings. We care about you and have fantastic financial and physical wellness options, such as: on-site massages, on-site counseling via our Employee Assistance Program, access to the Virgin Pulse Wellness tool, as well as other formal training and career development offerings to ensure you are meeting your career goals.
St. Luke's is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other status or condition protected by law.
*Please note: this posting is not reflective of all job duties and responsibilities and is intended to provide an overview to job seekers.
Senior Clinical Research Monitor
Posted today
Job Viewed
Job Description
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
We are searching for a **Senior Clinical Research Monitor** to join Edwards Aortic Field Monitoring team. As a Senior Clinical Research Monitor, you ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence. The ideal candidate will be based in the Western region.
**How you'll make an impact:**
+ Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
+ Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Act as a mentor to new or junior level employees.
+ Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements.
+ Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects.
+ Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
+ Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
+ Edit/amend informed consent documents.
**What you'll need (Required):**
+ Bachelor's Degree in related field or equivalent
+ 5 years of work experience in clinical research monitoring, with a strong focus on quality assurance, quality control, and regulatory compliance
+ Experience working in a regulated industry
+ Experience with electronic data capture
+ Ability to travel up to 75% for clinical site visits
+ Covid Vaccination
**What else we look for (Preferred):**
+ Knowledge of cardiovascular physiology and structural heart anatomy
+ Previous medical device Clinical Research experience in cardiology
+ Clinical research certification (ACRP or SOCRA, Clinical Coordinator/CRA certification)
+ Prior clinical research experience with Class III Medical Devices including PMA, IDE and 510(k)
+ Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required
+ Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software
**Additional skills:**
+ Demonstrated problem-solving and critical thinking skills
+ Excellent understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
+ Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
+ Technical writing skills (protocols, CRF development, study tools)
+ Ability to communicate and relate well with key opinion leaders and clinical personnel
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $106,000 to $140,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
**COVID Vaccination Requirement**
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Senior Clinical Research Associate - Oncology
Posted today
Job Viewed
Job Description
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