Clinical Research Project Manager B

University of Pennsylvania

22h • Onsite

About The Position

The Cardiovascular Clinical Research Unit (CCRU) supports a broad range of cardiovascular clinical trials across single-center and multicenter settings. The Project Manager B provides independent oversight of study operations, including project planning, team management, regulatory activities, and study execution. This role ensures studies are conducted according to protocol, regulatory requirements, and timelines, while supporting investigators and coordinating across internal and external collaborators.

Requirements

• Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is required.

Nice To Haves

• Master's degree and 3-5 years of experience preferred.

Responsibilities

• Independently manage complex, multi-site cardiovascular clinical research studies in collaboration with the Principal Investigator, including daily operations, study coordination, recruitment/enrollment oversight, and troubleshooting in accordance with Good Clinical Practice (GCP) and all applicable regulatory requirements.
• Lead study intake and drive start-up activities, including feasibility assessments, sponsor/CRO/vendor coordination, site activation, and completion of regulatory submissions and essential documents.
• Develop, create, and oversee regulatory submissions and study documentation, including protocols, informed consents, annual reports, safety reporting, and regulatory responses; assist with IND/IDE/CTA exemption determinations.
• Supervise, manage, and mentor study teams (typically 2–4 staff), including onboarding, training, workload management, and performance oversight; develop and drive study timelines, recruitment strategies, and operational plans.
• Contribute to budget development and PRA assessment in collaboration with investigators and finance teams; monitor study financial performance and ensure appropriate invoicing, billing, and reconciliation.
• Develop and maintain study tools and documentation, including source documents, case report forms (CRFs), manuals of procedures (MOPs), training materials, and standard operating procedures (SOPs).
• Lead internal and external study meetings (including sponsor, CRO, and multicenter collaborations); track action items and ensure timely resolution of issues.
• Oversee data quality, regulatory compliance, and study conduct, including audit/inspection readiness, monitoring follow-up, and quality control activities.
• Support multicenter coordination and external collaborations, including communication with partner sites, core labs, and external stakeholders as applicable.
• Perform additional duties as assigned.

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
• Generous retirement plans (Basic, Matching, and Supplemental)
• Substantial amount of time away from work
• Long-term care insurance
• Wellness and work-life resources
• Professional and personal development resources
• Access to a wide range of University resources, cultural and recreational activities
• Discounts on arts and entertainment, transportation, mortgages, new cars, cellular phone service plans, movie tickets, and theme parks
• Flexible work options
• Home ownership services (forgivable loan for eligible employees)
• Adoption assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level