Clinical Research Project Manager C

Opportunity for Health; Philadelphia (Philadelphia County); On-site; USD 91,000 - 107,000; Full time

Job summary

The Perelman School of Medicine at the University of Pennsylvania seeks a Regulatory/Project Manager C for the DOM CTU. You will provide regulatory oversight, manage studies from intake to close-out, supervise staff, and coordinate senior-level guidance across trials and disease areas.

Key tasks include preparing regulatory submissions, audit readiness, SOP and quality-review processes, budget support, and developing tools to improve study quality and efficiency.

Qualifications

• Master's degree and 5-7 years of related clinical research experience.
• Progressively responsible experience in regulatory affairs and project management.
• Experience supervising staff and coordinating multiple stakeholders.

Responsibilities

• Regulatory submissions, documentation, and approvals; senior regulatory resource.
• Audit/inspection preparation and responses, quality-review processes.
• Lead study intake, feasibility, start-up, implementation, and close-out.
• Develop project plans, tools, and budgets; monitor study quality and deliverables.
• Supervise assigned staff, onboarding, training, and performance evaluation.
• Coordinate routine unit administration and pursue funded work.

Skills

Regulatory affairs

Clinical research project management

Staff supervision

Education

Master's degree

Job description

**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 also coordinates routine unit administration, performing or delegating tasks while remaining accountable for timely completion. **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 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. Strong written and verbal communication, planning, organization, problem solving, attention to detail, and follow-through. Ability to manage competing priorities, anticipate and resolve study-related problems, maintain study quality, and meet deadlines. Proficiency with standard office, collaboration, and research-tracking tools.**Preferred**Experience in academic clinical research, SOP development, staff training, process improvement, and electronic regulatory document systems. A relevant master’s degree or research/regulatory certification is preferred. IND/IDE submission experience when relevant to assigned services, and experience communicating research services and developing collaborations, are preferred.**Job Location - City, State**Philadelphia, Pennsylvania**Department / School**Perelman School of Medicine**Pay Range**$91,066.00 - $106,940.00 Annual RateSalary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.