Senior Clinical Research Project Manager (CTU)

University of Pennsylvania; United States; On-site; USD 91,000 - 107,000; Full time

Benefits offered by this job

Health insurance

Tuition benefits

Retirement plans

Time away from work

Job summary

The Department of Medicine Clinical Trials Unit at the University of Pennsylvania seeks a Regulatory/Project Manager C to oversee regulatory submissions, staff supervision, and end‑to‑end management of phase I–IV studies. The role blends hands‑on regulatory work with strategic leadership across disease areas, ensuring compliance and quality.

Applicants should have a Master’s degree and 5–7 years of clinical research/regulatory experience.

Qualifications

• Master’s degree required with 5–7 years of related clinical research experience.
• Progressively responsible experience in regulatory affairs, clinical research project management, and staff supervision.
• Demonstrated ability to independently manage studies and regulatory work, coordinate stakeholders, supervise staff.

Responsibilities

• Prepare and oversee regulatory submissions, documentation, and approvals; act as senior regulatory resource.
• Lead study intake, feasibility, start‑up, implementation, and close‑out; develop plans and tools.
• Supervise assigned research staff; recruit, train, and evaluate performance; ensure SOP adherence.

Skills

Regulatory affairs

Clinical research PM

Staff supervision

IRB knowledge

Written/verbal communication

Planning & organization

Problem solving

Education

Master’s degree

Tools

Regulatory documentation

Job description

The Department of Medicine Clinical Trials Unit at the University of Pennsylvania seeks a Regulatory/Project Manager C to oversee regulatory submissions, staff supervision, and end‑to‑end management of phase I–IV studies. The role blends hands‑on regulatory work with strategic leadership across disease areas, ensuring compliance and quality.

Applicants should have a Master’s degree and 5–7 years of clinical research/regulatory experience.