Clinical Trials Regulatory & Project Manager

Trustees of University of Pennsylvania; Upper Paxton Township (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

The Department of Medicine Clinical Trials Unit (DOM CTU) at the University of Pennsylvania seeks a Regulatory/Project Manager C to support studies across disease areas, phases I–IV, and investigator-initiated and industry-sponsored trials.

Responsibilities include regulatory submissions, staff supervision, start-up through close-out, and contributing to protocol and grant development while pursuing funded work to sustain the unit.

Responsibilities

• Regulatory oversight for DOM CTU studies across phases I–IV.
• Lead regulatory submissions, documentation, and approvals.
• Supervise and develop research staff and ensure SOPs.
• Coordinate study intake, feasibility, start-up, and close-out.
• Assist with protocol and grant development, budgets, and resource planning.
• Drive unit sustainability by pursuing funded work and coordinating activities.

Job description

The Department of Medicine Clinical Trials Unit (DOM CTU) at the University of Pennsylvania seeks a Regulatory/Project Manager C to support studies across disease areas, phases I–IV, and investigator-initiated and industry-sponsored trials.

Responsibilities include regulatory submissions, staff supervision, start-up through close-out, and contributing to protocol and grant development while pursuing funded work to sustain the unit.