Manager Research Project A/B
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Posted Job Title
Manager Research Project 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
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 the 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 Affiliated Hospitals.
Project Manager A will continue to have Research Coordinator duties as needed to meet the needs of the CTU will have close supervision from Director on projects and will manage 1-2 staff.
Project Manager B will function autonomously as project manager on projects, including development and negotiation of study budgets, and will manage 2-4 staff.
QUALIFICATIONS:
PM A: A Bachelor's Degree and 3 - 5 years of related experience or equivalent combination of education and experience required.
PM B: A Master's Degree and 3- 5 years of related experience or equivalent combination of education and experience required.
PM A/B: Strong planning and organizational capabilities along with attention to detail, excellent follow-through, and problem-solving skills necessary. Must be effective in setting and meeting personal short and long-term goals to complete assignments, with multiple project tasks ongoing simultaneously. Successful candidates will have the ability to anticipate problems relating to projects and to develop and implement solutions. Flexibility and the drive to meet project deadlines are required. Knowledge of regulatory processes required. Excellent written and verbal skills are required.
Position contingent upon funding.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$50,684.00 - $91,232.00
Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
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