Senior Clinical Trial Leader
Johnson & Johnson
20 days ago
Remote friendly (Raynham, MA)
United States
Clinical Research and Development
Senior Clinical Trial Leader (CTL)
Responsibilities:
- Support planning and execution of one or more company-sponsored medical device clinical trials.
- Serve as Clinical Trial Leader for assigned studies; participate on clinical study core team.
- Partner with Clinical Franchise teams and Clinical Business Strategy & Development Managers to support study objectives.
- Ensure trials follow protocols, timelines, and regulatory requirements.
- Coordinate day-to-day operational activities (site communication, vendor collaboration); act as primary site contact.
- Identify/address operational challenges; escalate complex issues as appropriate.
- Track study budgets and support adherence to approved business plans.
- Share timely updates on study progress, milestones, and key events; support publications/deliverables as needed.
- Support compliance with GCP, applicable regulations, J&J policies; follow HSE guidelines; promote quality/safety/ethical conduct.
Qualifications:
- Bachelor’s degree or equivalent experience (preferred: Life Sciences, Physical Sciences, Nursing, Biological Sciences).
- 2–4 years relevant experience with clinical research/clinical operations/regulated environments.
Preferred:
- Clinical trial management or related research experience.
- Experience in medical device development/clinical programs; clinical/healthcare background.
- Certifications such as CCRA, RAC, or CDE.
Required skills/strengths:
- Working knowledge of GCP; understanding of clinical regulations across regions.
- Strong written/verbal communication; cross-functional collaboration; organized and detail-oriented; professionalism and ethical decision-making.
Benefits (time off): Vacation (120 hrs/yr), Sick time (40 hrs/yr), Holiday/Floating Holidays (13 days/yr), Work/Personal/Family Time (up to 40 hrs/yr), Parental Leave (480 hrs), Bereavement Leave (240 hrs immediate/40 hrs extended), Caregiver Leave (80 hrs/52-week period), Volunteer Leave (32 hrs/yr), Military Spouse Time-Off (80 hrs/yr).
Responsibilities:
- Support planning and execution of one or more company-sponsored medical device clinical trials.
- Serve as Clinical Trial Leader for assigned studies; participate on clinical study core team.
- Partner with Clinical Franchise teams and Clinical Business Strategy & Development Managers to support study objectives.
- Ensure trials follow protocols, timelines, and regulatory requirements.
- Coordinate day-to-day operational activities (site communication, vendor collaboration); act as primary site contact.
- Identify/address operational challenges; escalate complex issues as appropriate.
- Track study budgets and support adherence to approved business plans.
- Share timely updates on study progress, milestones, and key events; support publications/deliverables as needed.
- Support compliance with GCP, applicable regulations, J&J policies; follow HSE guidelines; promote quality/safety/ethical conduct.
Qualifications:
- Bachelor’s degree or equivalent experience (preferred: Life Sciences, Physical Sciences, Nursing, Biological Sciences).
- 2–4 years relevant experience with clinical research/clinical operations/regulated environments.
Preferred:
- Clinical trial management or related research experience.
- Experience in medical device development/clinical programs; clinical/healthcare background.
- Certifications such as CCRA, RAC, or CDE.
Required skills/strengths:
- Working knowledge of GCP; understanding of clinical regulations across regions.
- Strong written/verbal communication; cross-functional collaboration; organized and detail-oriented; professionalism and ethical decision-making.
Benefits (time off): Vacation (120 hrs/yr), Sick time (40 hrs/yr), Holiday/Floating Holidays (13 days/yr), Work/Personal/Family Time (up to 40 hrs/yr), Parental Leave (480 hrs), Bereavement Leave (240 hrs immediate/40 hrs extended), Caregiver Leave (80 hrs/52-week period), Volunteer Leave (32 hrs/yr), Military Spouse Time-Off (80 hrs/yr).