Clinical Research Project Manager B (Department of Obstetrics and Gynecology

Position: Clinical Research Project Manager B (Department of Obstetrics and Gynecology)
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Posted Job Title

Clinical Research Project Manager B (Department of Obstetrics and Gynecology)

Job Profile Title

Clinical Research Project Manager B

Job Description Summary

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.

Job Description

Job Responsibilities

The primary responsibility of the Project Manager (PM) in the Gynecologic Oncology research unit is to oversee implementation of a growing research portfolio. He/she will 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. He/she will participate in hiring and oversight of CRCs and research assistants.

The PM will interact and collaborate with the clinical team who manage patient care and confirm eligibility. The PM will ensure research visits are scheduled and study procedures are performed per protocol and data are entered accurately per contract timelines. The PM will 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.

The PM will 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. The PM will train team members on best practices for patient education and communication. The PM will accurately document research activity in Penn Chart.

The PM will review core documents and contribute to the development of operational processes that will promote efficiency and ensure adherence to ICH/GCP and institutional policies. The PM will participate in research team meetings and ongoing protocol training/compliance meetings and will participate in the preparation of annual reports.

* Position contingent upon continued funding
* Qualifications

+ Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is required. Master's degree and 3-5 years of experience preferred.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$75,804.00 - $89,789.00 Annual Rate

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement  

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin   (including…