2,020 Research Leader jobs in the United States
Center Manager (Laboratory Research Leader)
Posted 3 days ago
Job Viewed
Job Description
Faculty and staff in the Department of Chemistry are committed to developing students' understanding of science and problem-solving skills and preparing them for careers in science and the health professions.
The Department of Chemistry is a part of the College of Arts and Sciences at Indiana University and offers a variety of outstanding employment opportunities such as academics, scientist positions, laboratory technicians, administrative and information technology support, fiscal services and purchasing, technical services (machinists, electronics, glass blowers), student and teaching services, and much more. Each and every individual in every role is integral to the success of the educational and research mission of the department, the College, and Indiana University as a whole.
More information about the Department of Chemistry.
More information about the College of Arts and Sciences.
Job Summary
A multi-institutional, federally funded Nanoscience Center seeks a highly organized and proactive individual to serve as Center Manager.
Department-Specific Responsibilities
- Responsible for coordinating the daily operations of the Center.
- Ensures effective communication among collaborators.
- Supports project deliverables, and helps to implement the Center's strategic vision across research, education, and outreach domains.
- Oversees the activities and staff of the laboratory, providing training to lab staff, and assuring observation of safety policies.
- Manages and coordinates laboratory activities and monitors the progression of research projects.
- Oversees day-to-day operations of the Center, including scheduling, communications, documentation, and progress tracking.
- Facilitates meetings, prepare agendas and minutes, and support logistics for Center-wide events, workshops, and reviews.
- Supports the preparation of annual reports, data collection, and internal/external evaluations of Center activities.
- Serves as the primary administrative contact for internal and external stakeholders, including partner institutions and advisory boards.
- Maintains internal documentation and external communications such as newsletters, website updates, and outreach materials.
- Coordinates with the Director of Broader Impacts Activities and Research Thrust Leads to align and integrate administrative functions with scientific and outreach objectives.
- Oversees management of laboratory including training of personnel in various techniques and analysis.
- Conducts large-scale surveys, research projects, and complex experiments.
- Ensures that lab safety policies and procedures are observed and maintains safety records.
- Oversees the set-up and maintenance of lab equipment.
- Assists in preparation of completed research reports or analyses on each project phase.
- Maintains inventory and orders supplies as necessary; oversees the disposal of hazardous waste.
- Maintains fiscal accountability of the program, including grant proposal development, and approves all expenditures for the laboratory.
Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.
EDUCATION
Required
- Bachelor's degree in science, engineering, business, public administration, or a related field
- Master's degree or PhD in STEM, administration, or a related field
Required
- 2 years of experience in project coordination, program management, or research administration
- Experience supporting federally funded centers or large-scale collaborative research projects.
Required
- Proficient communication skills
- Maintains a high degree of professionalism
- Demonstrates time management and priority setting skills
- Demonstrates a high commitment to quality
- Excellent organizational skills and ability to manage multiple priorities
- Excellent collaboration and team building skills
- Effectively coaches and delivers constructive feedback
- Instills commitment to organizational goals
- Familiarity with federal grant management or academic research environments
- Proficiency in project management tools and platforms
- Ability to work independently and collaboratively in a fast-paced, interdisciplinary environment
- Understanding of broader impacts and science communication is a plus
The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.
Work Location
Department of Chemistry
Advertised Salary
Salary Range: $55,000 - $65,000
Benefits Overview
For full-time staff employees, Indiana University offers a wide array of benefits including:
- Comprehensive medical and dental insurance
- Health savings account with generous IU contributions
- Healthcare and dependent care flexible spending accounts
- Basic group life insurance paid by IU
- Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance
- Base retirement plan with generous IU contributions, subject to vesting
- Voluntary supplemental retirement plan options
- Tuition subsidy for employees and family members taking IU courses
- 10 paid holidays plus a paid winter break each year
- Generous paid time off plans
- Paid leave for new parents and IU-sponsored volunteer events
- Employee assistance program (EAP)
Job Classification
Career Level: Operational
FLSA: Exempt
Job Function: Research
Job Family: Laboratory Research
Click here to learn more about Indiana University's Job Framework.
Posting Disclaimer
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
Equal Employment Opportunity
Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information .
Campus Safety and Security
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online . You may also request a physical copy by emailing IU Public Safety at or by visiting IUPD.
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Clinical Research Leader - JJMT Electrophysiology
Posted 1 day ago
Job Viewed
Job Description
Discovery & Pre-Clinical/Clinical Development
**Job Sub** **Function:**
Clinical Development & Research - Non-MD
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Irvine, California, United States of America
**Job Description:**
Johnson & Johnson MedTech - Electrophysiology division is currently seeking to fill two **Clinical Research Leader** positions. These role's preferred location is in Irvine, California however we are open to remote candidates within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
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
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at role will be responsible for leading and supporting clinical trials while encouraging strong positive relationships with co-workers across the organization.
**Key Responsibilities:**
+ Serve as a Clinical Research Lead to implement and run company sponsored clinical trials, ensuring compliance with timelines and study milestones, for JJMT Electrophysiology.
+ Oversight/execution of feasibility, selection, set up, conduct and closure of the trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
+ Serves as the main contact for clinical trial sites (e.g. site management).
+ Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal direction.
+ Ensure trial registration from study initiation through posting of results and support publications as needed; (e.g. on Management/oversight of ordering, tracking, and accountability of investigational products and trial materials.
+ Communicate and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
+ Lead all aspects of development and execution of Investigator agreements and trial payments.
+ Leads clinical data review to prepare data for statistical analyses and publications.
+ If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
+ If applicable, as part of a clinical study, may provide on-site procedural protocol compliance and data collection support to the center.
+ Contribute to the assessment of the literature and to the interpretations and disseminations of all evidence generated.
+ Responsible for clinical projects, through partnership with the study core team leading to delivery of clinical project commitments.
+ Responsible for communicating business related issues or opportunities to next management level. Function as a trusted resource of accurate, up-to-date project knowledge as requested by crucial team member.
+ Supervise and run assigned project budgets to ensure adherence to business plans.
+ Support clinical scientific discussions with regulatory agencies to drive support of the clinical and regulatory strategy.
+ Develop a strong understanding of the pipeline, product portfolio and business needs.
+ Serve as the clinical representative on the Product Development team
+ Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
+ Should develop a strong understanding of the pipeline, product portfolio and business needs
+ Generally runs work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations
+ Responsible for communicating business related issues or opportunities to next management level
+ Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
+ For those who supervise or lead staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
+ May perform other duties assigned as needed
**Qualifications:**
+ Minimum of a bachelor's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 6 years clinical research experience is required
**Or**
+ Master's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required
**Or**
+ PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 3 years clinical research experience is required
+ Experience with project/team leadership is required.
+ Relevant industry certifications are preferred (examples may include; CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
+ Medical device experience highly preferred.
+ CRO experience and site management and clinical site monitoring are assets.
+ Experience delivering presentations and writing clinical reports is preferred.
+ Up to 20% travel is required.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
#PULSE #EP
Clinical Research Leader - JJMT Electrophysiology
Posted 1 day ago
Job Viewed
Job Description
Discovery & Pre-Clinical/Clinical Development
**Job Sub** **Function:**
Clinical Development & Research - Non-MD
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Irvine, California, United States of America, Remote (US)
**Job Description:**
Johnson & Johnson MedTech - Electrophysiology division is currently seeking to fill two **Clinical Research Leader** positions. One position is located in Irvine, California and has a hybrid work schedule of 3 days a week on-site. The other position requires up to 50% travel for site visits. The field-based role can be done remotely. For the role that can be done remotely, while specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
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
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at role will be responsible for leading and supporting clinical trials while encouraging strong positive relationships with co-workers across the organization.
**Key Responsibilities:**
This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
In accordance with all applicable federal, state and local laws/regulations and Corporate JnJ MedTech, procedures and guidelines, this position:
+ Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones.
+ Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
+ May serve as the primary contact for clinical trial sites (e.g. site management);
+ Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);
+ Ensures applicable trial registration (e.g. on ) from study initiation through posting of results and support publications as needed.
+ Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials.
+ Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
+ Interfaces, collaborates and oversees Clinical Research Associates (CRAs);
+ Oversees and supports the development and execution of Investigator agreements and trial payments.
+ Is responsible for clinical data review to prepare data for statistical analyses and publications.
+ May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
+ May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), contributing to cross-functional alignment.
+ May provide on-site procedural protocol compliance and data collection support to the clinical trial sites.
+ Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.
+ Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
+ Supports planning, track and manage assigned project budgets to ensure adherence to business plans.
+ Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy.
+ May serve as the clinical representative on a New Product Development team.
+ May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant.
+ May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.
+ Manages and/or mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
+ May act as Clinical Safety Coordinator (See ANNEX I - Clinical Safety Coordinator Duties and Responsibilities);
+ May perform other duties assigned as needed.
+ Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
+ Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.
+ Should develop a strong understanding of the pipeline, product portfolio and business needs.
+ Generally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations.
+ Responsible for communicating business related issues or opportunities to next management level.
+ Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
+ Performs other duties assigned as needed.
**Qualifications:**
+ Minimum of a bachelor's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 6 years clinical research experience is required
**Or**
+ Master's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required
**Or**
+ PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 3 years clinical research experience is required
+ Experience with project/team leadership is required.
+ Relevant industry certifications are preferred (examples may include; CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
+ Medical device experience highly preferred.
+ CRO experience and site management and clinical site monitoring are assets.
+ Experience delivering presentations and writing clinical reports is preferred.
+ One position will require on-site work in Irvine, CA, on average up to 2-3 days weekly, as well as attendance at critical on-site meetings as scheduled. Travel for this position will be up to 20%. The other position will require up to 50% travel.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
#PULSE #EP
Clinical Research Leader - JJMT Electrophysiology
Posted 1 day ago
Job Viewed
Job Description
Discovery & Pre-Clinical/Clinical Development
**Job Sub** **Function:**
Clinical Development & Research - Non-MD
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Irvine, California, United States of America
**Job Description:**
Johnson & Johnson MedTech - Electrophysiology division is currently seeking a **Clinical Research Leader (PM)** position. This role's preferred location is in Irvine, California however we are open to remote candidates within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
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
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at Responsibilities:**
+ Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones.
+ Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
+ May serve as the primary contact for clinical trial sites (e.g. site management);
+ Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);
+ Ensures applicable trial registration (e.g. on ) from study initiation through posting of results and support publications as needed.
+ Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials.
+ Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
+ Interfaces, collaborates and oversees Clinical Research Associates (CRAs);
+ Oversees and supports the development and execution of Investigator agreements and trial payments.
+ Is responsible for clinical data review to prepare data for statistical analyses and publications.
+ May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
+ May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), contributing to cross-functional alignment.
+ May provide on-site procedural protocol compliance and data collection support to the clinical trial sites.
+ Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.
+ Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
+ Supports planning, track and manage assigned project budgets to ensure adherence to business plans.
+ Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy.
+ May serve as the clinical representative on a New Product Development team.
+ May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant.
+ May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.
+ Manages and/or mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
+ May act as Clinical Safety Coordinator.
+ May perform other duties assigned as needed.
+ Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
+ Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.
+ Should develop a strong understanding of the pipeline, product portfolio and business needs.
+ Generally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations.
+ Responsible for communicating business related issues or opportunities to next management level
+ Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
+ Performs other duties assigned as needed
**Qualifications:**
+ Minimum of a bachelor's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 6 years clinical research experience is required
**Or**
+ Master's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required
**Or**
+ PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 3 years clinical research experience is required
+ Experience with project/team leadership is required.
+ Relevant industry certifications are preferred (examples may include; CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
+ Medical device experience highly preferred.
+ CRO experience and site management and clinical site monitoring are assets.
+ Experience delivering presentations and writing clinical reports is preferred.
+ Up to 20% travel is required for this role.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
#PULSE #EP
Clinical Research Leader - JJMT Electrophysiology
Posted today
Job Viewed
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 no-style="text-align:left;">Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Clinical Development & Research – Non-MDJob Category:
Scientific/TechnologyAll Job Posting Locations:
Irvine, California, United States of America, Remote (US)Job Description:
Johnson & Johnson MedTech - Electrophysiology division is currently seeking to fill two Clinical Research Leader positions. One position is located in Irvine, California and has a hybrid work schedule of 3 days a week on-site. The other position requires up to 50% travel for site visits. The field-based role can be done remotely. For the role that can be done remotely, while specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
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
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at
This role will be responsible for leading and supporting clinical trials while encouraging strong positive relationships with co-workers across the organization.
Key Responsibilities:
This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
In accordance with all applicable federal, state and local laws/regulations and Corporate JnJ MedTech, procedures and guidelines, this position:
- Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones.
- Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
- May serve as the primary contact for clinical trial sites (e.g. site management);
- Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);
- Ensures applicable trial registration (e.g. on from study initiation through posting of results and support publications as needed.
- Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials.
- Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
- Interfaces, collaborates and oversees Clinical Research Associates (CRAs);
- Oversees and supports the development and execution of Investigator agreements and trial payments.
- Is responsible for clinical data review to prepare data for statistical analyses and publications.
- May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
- May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), contributing to cross-functional alignment.
- May provide on-site procedural protocol compliance and data collection support to the clinical trial sites.
- Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.
- Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
- Supports planning, track and manage assigned project budgets to ensure adherence to business plans.
- Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy.
- May serve as the clinical representative on a New Product Development team.
- May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant.
- May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.
- Manages and/or mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
- May act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities);
- May perform other duties assigned as needed.
- Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
- Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.
- Should develop a strong understanding of the pipeline, product portfolio and business needs.
- Generally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations.
- Responsible for communicating business related issues or opportunities to next management level.
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Performs other duties assigned as needed.
Qualifications:
Minimum of a bachelor’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 6 years clinical research experience is required
Or
Master’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required
Or
PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 3 years clinical research experience is required
Experience with project/team leadership is required.
Relevant industry certifications are preferred (examples may include; CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
Medical device experience highly preferred.
CRO experience and site management and clinical site monitoring are assets.
Experience delivering presentations and writing clinical reports is preferred.
One position will require on-site work in Irvine, CA, on average up to 2-3 days weekly, as well as attendance at critical on-site meetings as scheduled. Travel for this position will be up to 20%. The other position will require up to 50% travel.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
#PULSE #EP
Clinical Research Leader - JJMT Electrophysiology
Posted today
Job Viewed
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 no-style="text-align:left;">Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Clinical Development & Research – Non-MDJob Category:
Scientific/TechnologyAll Job Posting Locations:
Irvine, California, United States of AmericaJob Description:
Johnson & Johnson MedTech - Electrophysiology division is currently seeking to fill two Clinical Research Leader positions. These role's preferred location is in Irvine, California however we are open to remote candidates within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
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
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at
This role will be responsible for leading and supporting clinical trials while encouraging strong positive relationships with co-workers across the organization.
Key Responsibilities:
Serve as a Clinical Research Lead to implement and run company sponsored clinical trials, ensuring compliance with timelines and study milestones, for JJMT Electrophysiology.
Oversight/execution of feasibility, selection, set up, conduct and closure of the trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
Serves as the main contact for clinical trial sites (e.g. site management).
Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal direction.
Ensure trial registration from study initiation through posting of results and support publications as needed; (e.g. on
Management/oversight of ordering, tracking, and accountability of investigational products and trial materials.
Communicate and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
Lead all aspects of development and execution of Investigator agreements and trial payments.
Leads clinical data review to prepare data for statistical analyses and publications.
If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
If applicable, as part of a clinical study, may provide on-site procedural protocol compliance and data collection support to the center.
Contribute to the assessment of the literature and to the interpretations and disseminations of all evidence generated.
Responsible for clinical projects, through partnership with the study core team leading to delivery of clinical project commitments.
Responsible for communicating business related issues or opportunities to next management level. Function as a trusted resource of accurate, up-to-date project knowledge as requested by crucial team member.
Supervise and run assigned project budgets to ensure adherence to business plans.
Support clinical scientific discussions with regulatory agencies to drive support of the clinical and regulatory strategy.
Develop a strong understanding of the pipeline, product portfolio and business needs.
Serve as the clinical representative on the Product Development team
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
Should develop a strong understanding of the pipeline, product portfolio and business needs
Generally runs work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
For those who supervise or lead staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
May perform other duties assigned as needed
Qualifications:
Minimum of a bachelor’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 6 years clinical research experience is required
Or
Master’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required
Or
PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 3 years clinical research experience is required
Experience with project/team leadership is required.
Relevant industry certifications are preferred (examples may include; CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
Medical device experience highly preferred.
CRO experience and site management and clinical site monitoring are assets.
Experience delivering presentations and writing clinical reports is preferred.
Up to 20% travel is required.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
#PULSE #EP
Clinical Research Leader - JJMT Electrophysiology
Posted 28 days ago
Job Viewed
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
Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Clinical Development & Research – Non-MDJob Category:
Scientific/TechnologyAll Job Posting Locations:
Irvine, California, United States of America, Remote (US)Job Description:
Johnson & Johnson MedTech - Electrophysiology division is currently seeking to fill two Clinical Research Leader positions. One position is located in Irvine, California and has a hybrid work schedule of 3 days a week on-site. The other position requires up to 50% travel for site visits. The field-based role can be done remotely. For the role that can be done remotely, while specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
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
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at
This role will be responsible for leading and supporting clinical trials while encouraging strong positive relationships with co-workers across the organization.
Key Responsibilities:
This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
In accordance with all applicable federal, state and local laws/regulations and Corporate JnJ MedTech, procedures and guidelines, this position:
- Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones.
- Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
- May serve as the primary contact for clinical trial sites (e.g. site management);
- Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);
- Ensures applicable trial registration (e.g. on from study initiation through posting of results and support publications as needed.
- Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials.
- Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
- Interfaces, collaborates and oversees Clinical Research Associates (CRAs);
- Oversees and supports the development and execution of Investigator agreements and trial payments.
- Is responsible for clinical data review to prepare data for statistical analyses and publications.
- May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
- May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), contributing to cross-functional alignment.
- May provide on-site procedural protocol compliance and data collection support to the clinical trial sites.
- Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.
- Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
- Supports planning, track and manage assigned project budgets to ensure adherence to business plans.
- Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy.
- May serve as the clinical representative on a New Product Development team.
- May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant.
- May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.
- Manages and/or mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
- May act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities);
- May perform other duties assigned as needed.
- Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
- Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.
- Should develop a strong understanding of the pipeline, product portfolio and business needs.
- Generally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations.
- Responsible for communicating business related issues or opportunities to next management level.
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Performs other duties assigned as needed.
Qualifications:
Minimum of a bachelor’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 6 years clinical research experience is required
Or
Master’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required
Or
PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 3 years clinical research experience is required
Experience with project/team leadership is required.
Relevant industry certifications are preferred (examples may include; CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
Medical device experience highly preferred.
CRO experience and site management and clinical site monitoring are assets.
Experience delivering presentations and writing clinical reports is preferred.
One position will require on-site work in Irvine, CA, on average up to 2-3 days weekly, as well as attendance at critical on-site meetings as scheduled. The other position will require up to 50% travel.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
$105,000 - $169,050Additional Description f or Pay Transparency:
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)). This position is eligible to participate in the Company’s long-term incentive program. 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 Additional information can be found through the link below.Be The First To Know
About the latest Research leader Jobs in United States !
Clinical Research Leader (PM) - JJMT Electrophysiology
Posted 24 days ago
Job Viewed
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
Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Clinical Development & Research – Non-MDJob Category:
Scientific/TechnologyAll Job Posting Locations:
Irvine, California, United States of AmericaJob Description:
Johnson & Johnson MedTech - Electrophysiology division is currently seeking a Clinical Research Leader (PM) position. This position is located in Irvine, California and has a hybrid work schedule of 3 days a week on-site.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
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at
Key Responsibilities:
- Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones.
- Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
- May serve as the primary contact for clinical trial sites (e.g. site management);
- Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);
- Ensures applicable trial registration (e.g. on from study initiation through posting of results and support publications as needed.
- Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials.
- Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
- Interfaces, collaborates and oversees Clinical Research Associates (CRAs);
- Oversees and supports the development and execution of Investigator agreements and trial payments.
- Is responsible for clinical data review to prepare data for statistical analyses and publications.
- May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
- May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), contributing to cross-functional alignment.
- May provide on-site procedural protocol compliance and data collection support to the clinical trial sites.
- Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.
- Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
- Supports planning, track and manage assigned project budgets to ensure adherence to business plans.
- Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy.
- May serve as the clinical representative on a New Product Development team.
- May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant.
- May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.
- Manages and/or mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
- May act as Clinical Safety Coordinator.
- May perform other duties assigned as needed.
- Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
- Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.
- Should develop a strong understanding of the pipeline, product portfolio and business needs.
- Generally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations.
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
Qualifications:
Minimum of a bachelor’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 6 years clinical research experience is required
Or
Master’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required
Or
PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 3 years clinical research experience is required
Experience with project/team leadership is required.
Relevant industry certifications are preferred (examples may include; CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
Medical device experience highly preferred.
CRO experience and site management and clinical site monitoring are assets.
Experience delivering presentations and writing clinical reports is preferred.
This position will require on-site work in Irvine, CA, on average up to 2-3 days weekly. Up to 25% travel is required for this role.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
$105,000 - $169,050Additional Description for Pay Transparency:
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 dis ability, 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)). This position is eligible to participate in the Company’s long-term incentive program. 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 Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.HIV Vaccine Clinical Research Leader - Infectious Diseases (142215)
Posted 16 days ago
Job Viewed
Job Description
**Salary Range or Pay Grade**
$225,000 - 350,000 a year
**Description**
The Department of Medicine, Infectious Diseases Division at the University of Rochester School of Medicine & Dentistry is seeking a full-time academic faculty member at the Associate Professor or Full Professor level for a leadership position with an established preventive HIV vaccine clinical research site (HIV Vaccine Trials Network (HVTN)), which is funded by the National Institute of Allergy and Infectious Diseases (NIAID). Strong candidates will have previous experience in the conduct of vaccine clinical trials for HIV and/or COVID-19 and may have experience conducting other HIV prevention trials sponsored by NIAID. The successful candidate will also have an opportunity to participate in a clinical trials program in HIV therapeutics (Advancing Clinical Trials Globally (ACTG)), and/or non-HIV infectious diseases (Infectious Diseases Clinical Research Consortium (IDCRC)), both funded by the NIAID. A recruitment package to support the development of an aligned independent research program will be available to qualified individuals. Clinical responsibilities will include Infectious Diseases consultation and teaching in inpatient and outpatient settings at Strong Memorial Hospital and its affiliated AIDS Center.
The University of Rochester has a strong commitment to the principles of diversity and actively encourages applications from members of groups who are under-represented in higher education. The Finger Lakes region of New York offers an outstanding quality of life for individuals and families in terms of cost of living, public education, and commuting time.
Faculty rank and salary commensurate with qualifications and experience.
**Qualifications**
M.D. Degree or equivalent
Must obtain a New York State Medical License prior to start date
Eligible for a Faculty Appointment at the University of Rochester School of Medicine and Dentistry
Must meet all credentialing requirements
Board Certified in Infectious Diseases
Post offer Drug Screen and Health Assessment required
Compliance with University and New York State health requirements
**Application Instructions**
**If you already have an Interfolio account, please sign in to apply to this position. If not, please create an Interfolio account. For questions/concerns pertaining to the position, email **
_The referenced pay range represents the University's good faith and reasonable estimate of the base range of compensation for this faculty position. Individual salaries will be determined within the job's salary range and established based on (but not limited to) market data, experience and expertise of the individual, and with consideration to related position salaries. Alignment of clinical incentive-based compensation may also be applicable and will be discussed during the hiring process._
**Equal Employment Opportunity Statement**
EOE, including disability/protected veterans
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University's Mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Classes). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates for all persons consistent with our values and based on applicable law.
Data Analysis
Posted today
Job Viewed
Job Description
Need Banking domain experience. Good data analysis and SQL skills and very good with large data crunching. Minimum 5 years of hands-on analytical experience in working as a Data and Business Analyst. Experience leading projects end to end including international stakeholders. Conduct end-to-end evaluations of existing processes to design and implement process enhancements.