Senior Clinical Trial Leader
Johnson & Johnson
20 days ago
Remote friendly (West Chester, PA)
United States
Clinical Research and Development
Senior Clinical Trial Leader (CTL) — DePuy Synthes
About the Role
Support planning and execution of one or more clinical trials within Clinical Operations; collaborate with cross-functional colleagues, clinical sites, and external partners.
Clinical Trial Execution
- Support company-sponsored clinical trials within Medical Device franchises (under appropriate supervision).
- Serve as CTL for assigned studies; participate on the clinical study core team.
- Partner with Clinical Franchise colleagues and Clinical Business Strategy & Development Managers (BSDMs) to support study objectives.
- Ensure trials align with protocols, timelines, and regulatory requirements.
Operational Support & Collaboration
- Coordinate day-to-day study operations (site communication, vendor collaboration).
- Primary point of contact for clinical trial sites.
- Identify/address operational challenges; escalate complex issues appropriately.
- Track study budgets; support adherence to approved business plans.
- Assist with clinical systems, tools, and process improvements.
Communication & Knowledge Sharing
- Provide timely updates on progress, milestones, and key events.
- Support publications and other study deliverables as needed.
Compliance, Quality & Ethics
- Support GCP and applicable regulations; follow all related policies.
- Follow Health, Safety, and Environmental (HSE) guidelines.
Required
- Bachelor’s degree or equivalent; preferred: Life Sciences, Physical Sciences, Nursing, Biological Sciences.
- 2–4 years relevant experience in clinical research/clinical operations/regulated environments.
Preferred
- Clinical trial management or related research experience.
- Exposure to medical device development/clinical programs.
- Clinical/healthcare background.
- Certifications (e.g., CCRA, RAC, CDE).
Benefits (time off)
Vacation (120 hrs/yr), Sick time (40 hrs/yr), Holiday pay (13 days/yr), Work/Personal/Family time (up to 40 hrs/yr), Parental leave (480 hrs), Bereavement leave (240 hrs immediate family), Caregiver leave (80 hrs), Volunteer leave (32 hrs), Military spouse time-off (80 hrs).
About the Role
Support planning and execution of one or more clinical trials within Clinical Operations; collaborate with cross-functional colleagues, clinical sites, and external partners.
Clinical Trial Execution
- Support company-sponsored clinical trials within Medical Device franchises (under appropriate supervision).
- Serve as CTL for assigned studies; participate on the clinical study core team.
- Partner with Clinical Franchise colleagues and Clinical Business Strategy & Development Managers (BSDMs) to support study objectives.
- Ensure trials align with protocols, timelines, and regulatory requirements.
Operational Support & Collaboration
- Coordinate day-to-day study operations (site communication, vendor collaboration).
- Primary point of contact for clinical trial sites.
- Identify/address operational challenges; escalate complex issues appropriately.
- Track study budgets; support adherence to approved business plans.
- Assist with clinical systems, tools, and process improvements.
Communication & Knowledge Sharing
- Provide timely updates on progress, milestones, and key events.
- Support publications and other study deliverables as needed.
Compliance, Quality & Ethics
- Support GCP and applicable regulations; follow all related policies.
- Follow Health, Safety, and Environmental (HSE) guidelines.
Required
- Bachelor’s degree or equivalent; preferred: Life Sciences, Physical Sciences, Nursing, Biological Sciences.
- 2–4 years relevant experience in clinical research/clinical operations/regulated environments.
Preferred
- Clinical trial management or related research experience.
- Exposure to medical device development/clinical programs.
- Clinical/healthcare background.
- Certifications (e.g., CCRA, RAC, CDE).
Benefits (time off)
Vacation (120 hrs/yr), Sick time (40 hrs/yr), Holiday pay (13 days/yr), Work/Personal/Family time (up to 40 hrs/yr), Parental leave (480 hrs), Bereavement leave (240 hrs immediate family), Caregiver leave (80 hrs), Volunteer leave (32 hrs), Military spouse time-off (80 hrs).