Clinical Research Project Lead — Regulatory & Trials Expert

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

Benefits offered by this job

Health insurance

Tuition benefits

Retirement plans

Wellness programs

Job summary

University of Pennsylvania in Philadelphia seeks a Regulatory/Project Manager C to provide regulatory expertise and oversight for the Department of Medicine Clinical Trials Unit. You will manage regulatory submissions, lead project teams, and supervise staff across trials from intake to close-out.

Requirements include a Master’s degree and 5–7 years in regulatory affairs and clinical research project management. Strong communication and organizational skills are essential.

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.
• Knowledge of IRB processes, human research protection requirements, GCP, and regulatory documentation.

Responsibilities

• Prepare and oversee regulatory submissions, documentation, and approvals; serve as a senior regulatory resource.
• Lead study intake, feasibility, start-up, implementation, and close-out; develop project plans and study tools.
• Supervise assigned research staff, provide training, and evaluate performance.

Skills

Regulatory affairs

Clinical research PM

Staff supervision

IRB processes

Regulatory documentation

Education

Master's degree

Tools

Office tools

Job description

University of Pennsylvania in Philadelphia seeks a Regulatory/Project Manager C to provide regulatory expertise and oversight for the Department of Medicine Clinical Trials Unit. You will manage regulatory submissions, lead project teams, and supervise staff across trials from intake to close-out.

Requirements include a Master’s degree and 5–7 years in regulatory affairs and clinical research project management. Strong communication and organizational skills are essential.