Clinical Research Project Manager C

University of Pennsylvania Perelman School of Medicine

6d•$91,066 - $106,940

About The Position

The Regulatory/Project Manager C provides regulatory expertise and oversight, project management, and staff supervision for the University of Pennsylvania Department of Medicine Clinical Trials Unit (DOM CTU). The role supports phase I–IV clinical trials, including investigator-initiated and industry-sponsored research across disease areas and varying levels of complexity. It combines hands-on study and regulatory work with senior-level consultation and leadership of complex projects when assigned. The manager independently prepares and oversees regulatory submissions, documentation, and approvals; advises on regulatory approaches; and addresses complex compliance issues. The role also leads studies from intake through close-out, plans and coordinates project work, supervises and develops staff, and supports improvements to study quality and operational effectiveness. The manager helps secure funded work to sustain the position and contributes to funding and assignment development for other DOM CTU staff, while coordinating routine unit administration.

Requirements

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.
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.

Nice To Haves

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.
IND/IDE submission experience when relevant to assigned services.
Experience communicating research services and developing collaborations.

Responsibilities

Independently prepare and oversee regulatory submissions, documentation, and approvals.
Serve as a senior regulatory resource, advise on regulatory approaches, and resolve complex compliance issues.
Prepare for audits and inspections, respond to findings, coordinate corrective actions, and support regulatory SOPs and quality-review processes.
Perform IND/IDE exemption assessments and submissions when included in assigned services.
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.
Lead project teams, resolve operational barriers, develop performance metrics, and monitor study quality, recruitment, scope, budgets, and deliverables.
Advise on resource deployment and implement improvements across assigned projects.
Directly supervise assigned research staff, including assigning work, monitoring workload and quality, onboarding, training, coaching, and evaluating performance.
Participate in recruitment and address staff performance and development needs.
Promote consistent use of SOPs, study tools, and best practices across assigned teams.
Market DOM CTU staff and services and take primary responsibility for securing funded work to sustain the position.
Share responsibility for pursuing and securing assignments for other CTU staff to support unit-wide financial sustainability.
Coordinate routine unit administration, performing or delegating tasks and remaining accountable for timely completion.

Benefits

Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits.
Flexible spending accounts for eligible health care and dependent care expenses.
Tuition assistance for employees, spouses, and dependent children at Penn; dependent children may also receive assistance at other institutions.
Basic, matching, and supplemental retirement plans.
Substantial time away from work during the year.
Long-term care insurance.
Wellness and work-life programs and resources.
Professional and personal development resources.
Access to University resources, including libraries, athletic facilities, cultural activities, and recreational activities.
Discounts and special services, including arts and cultural venues, transportation, and other goods and services.
Flexible work options and hours.
Forgivable homeownership loan for eligible employees buying a home or residing in West Philadelphia.
Adoption assistance reimbursement for eligible expenses, for up to two adoptions in the household.