Senior Clinical Trials Project Manager

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

Benefits offered by this job

Health benefits

Tuition assistance

Retirement plans

Time off

Wellness programs

Professional development

Job summary

The University of Pennsylvania’s Department of Medicine Clinical Trials Unit (DOM CTU) seeks a Regulatory/Project Manager C to provide regulatory oversight, hands-on project management, and staff supervision for a diverse portfolio of studies from phase I to IV across multiple disease areas.

Responsibilities include preparing regulatory submissions, advising on regulatory approaches, leading study intake and start-up, coordinating budgets and resources, and mentoring junior staff.

Qualifications

• Master's degree and 5-7 years of related clinical research experience, or an equivalent combination of education and experience.
• Progressively responsible experience in regulatory affairs, clinical research project management, and staff supervision.
• Ability to independently manage assigned studies and regulatory work, coordinate multiple stakeholders, and supervise, train, and evaluate staff.
• Demonstrated knowledge of IRB processes, human research protection requirements, Good Clinical Practice, and regulatory documentation.

Responsibilities

• Provide regulatory oversight, project management, and staff supervision for the Department of Medicine Clinical Trials Unit (DOM CTU).
• Support phase I–IV, investigator-initiated, and industry-sponsored research across disease areas and levels of complexity.
• Prepare and oversee regulatory submissions, documentation, and approvals; serve as a senior regulatory resource; advise on regulatory approaches.
• Lead study intake, feasibility, start-up, implementation, and close-out; develop project plans and study tools; contribute to protocol and grant development, budgets, and resource planning.
• Supervise assigned research staff, including work assignment, workload and quality monitoring, onboarding, training, coaching, and performance evaluation.
• Proactively market DOM CTU staff and services, secure funded work, and coordinate routine unit administration while remaining accountable for timely completion.

Skills

Regulatory affairs

Clinical research PM

Staff supervision

IRB processes

GCP

Project management

Education

Master's degree

Tools

Office tools

Job description

The University of Pennsylvania’s Department of Medicine Clinical Trials Unit (DOM CTU) seeks a Regulatory/Project Manager C to provide regulatory oversight, hands-on project management, and staff supervision for a diverse portfolio of studies from phase I to IV across multiple disease areas.

Responsibilities include preparing regulatory submissions, advising on regulatory approaches, leading study intake and start-up, coordinating budgets and resources, and mentoring junior staff.