Clinical Research Project Manager B (Department of Obstetrics and Gynecology)
About The Position
The Gynecologic Oncology research program has seen substantial growth in the volume and complexity of Phase 1–3 clinical trials. This role will provide essential high-level oversight and coordination of our expanding trial portfolio, including study activation, regulatory compliance, sponsor/CRO interactions, cross-functional team management, and process improvement initiatives. The Project Manager B will manage critical operational aspects such as DOCM audits, Veeva Clinical Vault, REDCap database development, and risk mitigation, allowing the team to maintain high standards of data quality, patient safety, and regulatory compliance while supporting continued program expansion and the advancement of novel therapies for women with gynecologic cancers.
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
- Oversee implementation of a growing research portfolio.
- Collaborate with the Director and Associate Director to coordinate study start-up activities and feasibility assessments including preparation of study budgets and obtaining quotes from collaborating units.
- Participate in hiring and oversight of CRCs and research assistants.
- Interact and collaborate with the clinical team who manage patient care and confirm eligibility.
- Ensure research visits are scheduled and study procedures are performed per protocol and data are entered accurately per contract timelines.
- Interact with study sponsors’ teams, report to the IRB, coordinate research activities with specialty labs, the investigational pharmacy, Center for Phenomic Medicine and the Cell Center.
- Oversee patient education for complex trials assuring that study activities and procedures are explained to patients and family members in lay terms and utilizing teach back methods to confirm patients and families understand what is required to participate in the study.
- Train team members on best practices for patient education and communication.
- Accurately document research activity in Penn Chart.
- Review core documents and contribute to the development of operational processes that will promote efficiency and ensure adherence to ICH/GCP and institutional policies.
- Participate in research team meetings and ongoing protocol training/compliance meetings.
- Participate in the preparation of annual reports.
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 programs and resources
- Professional and personal development resources
- Access to a wide range of University resources, cultural and recreational activities
- Discounts on arts and entertainment, transportation, and mortgages
- Flexible work hours
- Forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia
- Adoption assistance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
