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Posted Job Title

Project Manager A/B
Job Profile Title

Manager Research Project 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

Job Responsibilities

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 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 perform regulatory duties including regulatory oversight, regulatory submissions, and compliance checks. S/he will participate in documentation of best practices and SOPs. S/he will participate in the Department of Medicine research initiatives including the Training Program and Activation of Clinical Research at Penn Affiliate Hospitals.

DUTIES:

Project Manager A: Supervise, manage and train study teams, including developing and driving study timelines and strategies, and directly manage 1-2 staff.

PM-A: With supervision, manage research studies conducted through the DOM Clinical Trials Unit in accordance with Good Clinical Practice guidelines and all applicable regulatory guidelines.

PM-A: Conduct study related visits and procedures, including recruitment, when needed to meet the needs of DOM CTU Research Projects.

PM-A: With supervision, develop, create and review regulatory submissions, including protocols, consents, annual reports, unanticipated problems, etc., and address regulatory reviewer inquiries. Provide assistance with IND/IDE/CTA exemption determinations.

PM-A: Manage study budgets and assure payments are received and paid out in a timely manner.

Oversee data and sample management, including compliance checks and helping teams prepare for audits.

Develop source docs, training slides, manual of procedures, CRFs and SOPs related to each study.

Lead internal and external meetings and ensure unresolved issues are followed to resolution.

Perform other duties as needed.

Project Manager B: Supervise, manage and train study teams, including developing and driving study timelines and strategies, and directly manage 2-4 staff.

PM -B: With directly with primary investigator to manage research studies conducted through the DOM Clinical Trials Unit in accordance with Good Clinical Practice guidelines and all applicable regulatory guidelines.

PM-B: Develop, create and review regulatory submissions, including protocols, consents, annual reports, unanticipated problems, etc., and address regulatory reviewer inquiries. Provide assistance with IND/IDE/CTA exemption determinations.

PM-B: Develop, negotiate and manage study budgets and assure payments are received and paid out in a timely manner.

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.

Develop source docs, training slides, manual of procedures, CRFs and SOPs related to each study.

Lead internal and external meetings and ensure unresolved issues are followed to resolution.

Perform other duties as needed.