Clinical Trials Program Manager

University of Pennsylvania; United (PA); On-site; USD 91,000 - 107,000; Full time

Job summary

The University of Pennsylvania in Philadelphia, PA, seeks a Clinical Research Project Manager C to oversee regulatory affairs and multi-study coordination within the Department of Medicine Clinical Trials Unit (DOM CTU). You will manage regulatory submissions, quality controls, and staff development across diverse clinical trials.

Requires a Master’s degree and 5–7 years of clinical research experience, with strong knowledge of IRB processes and GCP.

Qualifications

• Master's degree and 5-7 years of related clinical research experience, or an equivalent combination of education and experience required.
• Progressively responsible experience in regulatory affairs, clinical research project management, and staff supervision.
• Demonstrated knowledge of IRB processes, human research protection requirements, Good Clinical Practice, and regulatory documentation.
• Strong written and verbal communication, planning, organization, problem solving, attention to detail, and follow-through.

Responsibilities

• Provide regulatory expertise and oversight for the DOM CTU across phase I–IV studies.
• Lead project management and supervise study staff; coordinate multiple stakeholders.
• Prepare regulatory submissions, documentation, and approvals; ensure compliance and quality.

Skills

Regulatory affairs

Clinical research PM

Staff supervision

IRB processes

Communication

Education

Master's degree

Job description

The University of Pennsylvania in Philadelphia, PA, seeks a Clinical Research Project Manager C to oversee regulatory affairs and multi-study coordination within the Department of Medicine Clinical Trials Unit (DOM CTU). You will manage regulatory submissions, quality controls, and staff development across diverse clinical trials.

Requires a Master’s degree and 5–7 years of clinical research experience, with strong knowledge of IRB processes and GCP.