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Project Manager a / B
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- 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.
- 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.
- S/he will play a key role in study start-up, intake & feasibility for many studies.
- Oversee data and sample management, including compliance checks and helping teams prepare for audits.
- Lead study intake and drive study start-up for trials including feasibility assessments, liaising with sponsors, vendors, CROs & PI teams, and completing start-up regulatory documents and submissions.
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