Senior Clinical Trial Leader
Johnson & Johnson
19 days ago
Remote friendly (Warsaw, IN)
United States
Clinical Research and Development
About The Role
Senior Clinical Trial Leader (CTL) supports planning and execution of one or more clinical trials within Clinical Operations, partnering with cross-functional colleagues, clinical sites, and external partners.
Clinical Trial Execution
- Support execution of company-sponsored clinical trials within Medical Device franchises.
- Serve as Clinical Trial Leader for assigned studies and 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 operational activities (site communication, vendor collaboration).
- May serve as primary point of contact for clinical trial sites.
- Identify/address operational challenges; escalate complex issues as appropriate.
- Track study budgets and support adherence to approved business plans.
- Assist with implementation of clinical systems, tools, and process improvements.
Communication & Compliance
- Provide timely updates on progress, milestones, and key events.
- Support publications and study deliverables.
- Support compliance with GCP and applicable regulations/policies; follow HSE guidelines.
Required
- Bachelor’s degree (or equivalent); preferred Life/Physical/Nursing/Biological Sciences.
- 2–4 years relevant experience with clinical research/clinical operations/regulated environments.
Preferred
- Clinical trial management or related roles; medical device development/clinical programs.
- Clinical/healthcare background; CCRA, RAC, or CDE.
Benefits (time off)
- Vacation 120 hrs/year; Sick time 40 hrs/year (CO 48; WA 56).
- 13 holidays; Work/Personal/Family time up to 40 hrs/year; Parental leave 480 hrs; Bereavement 240 hrs (immediate); Caregiver leave 80 hrs; Volunteer 32 hrs; Military spouse time-off 80 hrs/year.
Senior Clinical Trial Leader (CTL) supports planning and execution of one or more clinical trials within Clinical Operations, partnering with cross-functional colleagues, clinical sites, and external partners.
Clinical Trial Execution
- Support execution of company-sponsored clinical trials within Medical Device franchises.
- Serve as Clinical Trial Leader for assigned studies and 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 operational activities (site communication, vendor collaboration).
- May serve as primary point of contact for clinical trial sites.
- Identify/address operational challenges; escalate complex issues as appropriate.
- Track study budgets and support adherence to approved business plans.
- Assist with implementation of clinical systems, tools, and process improvements.
Communication & Compliance
- Provide timely updates on progress, milestones, and key events.
- Support publications and study deliverables.
- Support compliance with GCP and applicable regulations/policies; follow HSE guidelines.
Required
- Bachelor’s degree (or equivalent); preferred Life/Physical/Nursing/Biological Sciences.
- 2–4 years relevant experience with clinical research/clinical operations/regulated environments.
Preferred
- Clinical trial management or related roles; medical device development/clinical programs.
- Clinical/healthcare background; CCRA, RAC, or CDE.
Benefits (time off)
- Vacation 120 hrs/year; Sick time 40 hrs/year (CO 48; WA 56).
- 13 holidays; Work/Personal/Family time up to 40 hrs/year; Parental leave 480 hrs; Bereavement 240 hrs (immediate); Caregiver leave 80 hrs; Volunteer 32 hrs; Military spouse time-off 80 hrs/year.