Clinical Research Project Manager C

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

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Posted Job Title

Clinical Research Project Manager C

Job Profile Title

Clinical Research Project Manager C

Job Description Summary

The Department of Medicine Clinical Trials Unit (DOM CTU) supports a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states and varying complexities. Our projects occur throughout the Department of Medicine including Cardiology, Pulmonary, Rheumatology, Translational Medicine, Gastroenterology, Infectious Disease, General Medicine, Sleep, HemOnc, Endocrine, Renal and Geriatrics. To learn more about DOM CTU visit https://www.med.upenn.edu/pennctu/.

The Regulatory/Project Manager C provides regulatory expertise and oversight, project management, and staff supervision for the Department of Medicine Clinical Trials Unit (DOM CTU). The position supports studies across disease areas, phases, and levels of complexity, combining hands‑on work with senior‑level consultation, regulatory planning, and leadership of complex projects when assigned. The manager independently performs and oversees regulatory activities, manages studies from intake through close‑out, supervises and develops staff, and improves study quality and operational effectiveness. Additional responsibilities include securing funded work for this position, pursuing work for other DOM CTU staff to support unit‑wide sustainability, and coordinating routine unit administration.

Job Description

Job Responsibilities

The Regulatory/Project Manager C provides regulatory expertise and oversight, project management, and staff supervision for the Department of Medicine Clinical Trials Unit (DOM CTU). The position supports phase I-IV, investigator-initiated, and industry-sponsored research across disease areas and levels of complexity. Responsibilities combine hands‑on support and ongoing study management with senior‑level consultation and leadership of complex projects when assigned.

The position independently prepares and oversees regulatory submissions, documentation, and approvals; serves as a senior regulatory resource; advises on regulatory approaches; and resolves complex compliance issues. Responsibilities include audit/inspection preparation and responses, corrective actions, regulatory SOPs and quality-review processes, and IND/IDE exemption assessments and submissions when included in assigned services.

The manager leads study intake, feasibility, start‑up, implementation, and close‑out; develops project plans and study tools; and contributes to protocol and grant development, budgets, and resource planning. The position leads project teams, resolves operational barriers, develops performance metrics, and monitors study quality, recruitment, scope, budgets, and deliverables. The manager advises on resource deployment and implements improvements across assigned projects.

The position directly supervises assigned research staff, including work assignment, workload and quality monitoring, onboarding, training, coaching, and performance evaluation. The manager participates in recruitment, addresses performance and development needs, and promotes consistent use of SOPs, study tools, and best practices across assigned teams.

Additional responsibilities include proactively marketing DOM CTU staff and services, taking primary responsibility for securing funded work to sustain this position, and sharing responsibility for pursuing and securing assignments for other CTU staff to support unit‑wide financial sustainability. The manager