Clinical Research Project Manager A

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Posted Job Title

Clinical Research Project Manager A

Job Profile Title

Clinical Research Project Manager A

Job Description Summary

As part of the Department of Medicine, the DOM Clinical Trials Unit supports a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states and varying complexities. Project Manager work includes overall management of research projects, supervision of research staff, regulatory submissions, recruitment strategy, and development of key study documents include protocol, consent, and CRFs. Our projects occur throughout the Department of Medicine including Cardiology, Pulmonary, Rheumatology, Translational Medicine, Gastroenterology, Infectious Disease, General Medicine, Sleep, HemOnc, Endocrine, Renal and Geriatrics. To learn more about DOM CTU visit https://www.med.upenn.edu/pennctu/.

Job Description

The Project Manager will provide project management and regulatory support and expertise associated with clinical trials for the Penn Department of Medicine’s Clinical Trials Unit.  The person will work closely with the Director of Clinical Research Operations to support a diverse group of investigators and coordinators, involving work on a wide spectrum of clinical trials ranging from phase I-IV, investigator/industry-initiated, different disease states and varying complexities.  Involvement will range from consulting to serving as the project manager for a study having primary responsibility with respect to execution and operational planning of the studies and accountability for results. The Project Manager will oversee the delivery of patient care as defined in the study protocols.  The Project Manager will manage/supervise the study teams assuring that each clinical trial meets expectations and that they are conducted in accordance with the specific clinical protocol as approved by the Sponsor, study team and in accordance with all regulatory organizations.  S/he will play a key role in study start-up, intake & feasibility for many studies.  The Project Manager A will continue to have Research Coordinator duties as needed to meet the needs of the CTU.

The Project Manager will provide oversight and support for each study team, lead team meetings, drive study timelines, recruitment, and overall performance.  S/he will generate study specific plans and documents, provide input and management of study budgets, and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.  S/he will lead problem solving and resolution efforts, and review study status and monitor reports to identify and address possible issues.  S/he will provide leadership and guidance to research personnel in their day-to-day operational activities.  S/he will p