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University of Pennsylvania
Clinical Research Project Manager A
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What they do
A Clinical Research Manager is responsible for managing the day-to-day research operations of an organization undertaking clinical trials, usually pharmacological drug testing.
$152,267 / year median in Pennsylvania
Job Description
Clinical Research Project Manager A University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more. 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 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. Qualifications Bachelor's Degree with 3-5 years of related experience or equivalent combination of education and experience is required. 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 required. Knowledge of regulatory processes required. Excellent written and verbal skills required. Position contingent upon funding. Job Location - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $63,085.00 - $75,000.00 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 shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law. Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.