Senior Regulatory Clinical Trials Project Manager

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

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.