Regulatory & Clinical Trials Project Manager

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

Job summary

University of Pennsylvania’s Perelman School of Medicine seeks a Regulatory/Project Manager C within the DOM CTU in Philadelphia. The role combines regulatory oversight with project management and staff supervision across phase I–IV and industry-sponsored research.

The manager will prepare regulatory submissions, advise on regulatory approaches, and lead complex projects while coordinating with multiple stakeholders and ensuring study quality and timelines.

Qualifications

• Master’s degree and 5-7 years of related clinical research experience or equivalent combination.
• Progressively responsible experience in regulatory affairs, clinical research project management, and staff supervision.
• Ability to independently manage studies and regulatory work, coordinate stakeholders, supervise and train staff.

Responsibilities

• Provide regulatory expertise and oversight for phase I–IV studies.
• Prepare and oversee regulatory submissions and approvals; advise on approaches.
• Lead study intake, feasibility, start-up, and close-out; develop plans and tools.
• Supervise assigned research staff, recruit and evaluate performance.
• Secure funded work and coordinate routine unit administration.

Skills

Regulatory affairs

Project management

Staff supervision

IRB knowledge

Communication

Education

Master’s degree in related field

Job description

University of Pennsylvania’s Perelman School of Medicine seeks a Regulatory/Project Manager C within the DOM CTU in Philadelphia. The role combines regulatory oversight with project management and staff supervision across phase I–IV and industry-sponsored research.

The manager will prepare regulatory submissions, advise on regulatory approaches, and lead complex projects while coordinating with multiple stakeholders and ensuring study quality and timelines.