Clinical Research Project Manager B

Job Description Summary

The Penn Neurogenetics Therapy Center (PNTC) supports a diverse group of neurogenetics investigators and clinical research professionals, involving work on investigator-initiated clinical research studies and complex industry-sponsored, first-in-human trials of gene therapies for neurological diseases. The Clinical Research Project Manager B (CRPM B) provides end-to-end management across the full study lifecycle (startup, conduct, and closeout) of assigned clinical research studies conducted in collaboration with internal Penn entities and external sponsors with limited oversight from senior PNTC operational leadership. This position supports principal investigators and directly supervises study teams in the successful implementation and execution of complex clinical research in compliance with study protocols, institutional policies, federal regulations, and Good Clinical Practice (GCP).

Job Description

Job Responsibilities

• Clinical Research Project Management: Serve as the primary operational point of contact for assigned studies, coordinating study activities among investigators, study teams, internal partners, and external sponsors. Ensure protocol adherence, timely milestone completion, and alignment with established timelines and study requirements. Collaborate with finance and administrative personnel to conduct pre-post-award activities, monitor study finances and address discrepancies or risks.
• Regulatory and Study Documentation Oversight: Develop, review, and oversee the maintenance of regulatory and study documents. Ensure maintenance or regulatory approvals and compliance with all applicable requirements. Prepare and deliver study progress reports to internal leadership and external sponsors, as required.
• Staff Supervision and Leadership: Independently onboard, train, supervise and mentor direct and/or indirect research staff in accordance with protocol requirements and institutional standards. Assign project responsibilities, support professional development, and complete performance evaluations.
• Process Improvement: Lead and contribute to the development, implementation, and continuous improvement of center- and study-level clinical research processes and standard operating procedures.
• Perform additional duties as assigned by senior operational leadership in support of clinical research operations and strategic initiatives.

Qualifications

• Master's degree and 3-5 years of experience or an equivalent combination of education and experience required.
• Preferred: Must be organized and able to prioritize; effective communication and writing skills; strong time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently.