Clinical Research Project Manager C

Clinical Research Project Manager C University Overview The University of Pennsylvania, the largest private employer inPhiladelphia, is a world-renowned leader in education, research,and innovation. This historic, Ivy League school consistently ranksamong the top 10 universities in the annual U.S. News & WorldReport survey. Penn has 12 highly-regarded schools that provideopportunities for undergraduate, graduate and continuing education,all influenced by Penn's distinctive interdisciplinary approach toscholarship and learning. As an employer Penn has been rankednationally on many occasions with the most recent award from Forbeswho named Penn one of America's Best Large Employers in 2023. Penn offers a unique working environment within the city ofPhiladelphia. The University is situated on a beautiful urbancampus, with easy access to a range of educational, cultural,andrecreational activities. With its historical significance andlandmarks, lively cultural offerings, and wide variety ofatmospheres, Philadelphia is the perfect place to call home forwork and play. The University offers a competitive benefits package that includesexcellent healthcare and tuition benefits for employees and theirfamilies, generous retirement benefits, a wide variety ofprofessional development opportunities, supportive work and familybenefits, a wealth of health and wellness programs and resources,and much more. Posted Job Title Clinical Research Project Manager C Job Profile Title Clinical Research Project Manager C Job Description Summary The Department of Medicine Clinical Trials Unit (DOM CTU) supportsa diverse group of investigators, involving work on a wide spectrumof clinical trials ranging from phase I to IV, investigator andindustry initiated, different disease states and varyingcomplexities. Our projects occur throughout the Department ofMedicine including Cardiology, Pulmonary, Rheumatology,Translational Medicine, Gastroenterology, Infectious Disease,General Medicine, Sleep, HemOnc, Endocrine, Renal and Geriatrics.To learn more about DOM CTU visit The Regulatory/Project Manager C provides regulatory expertise andoversight, project management, and staff supervision for theDepartment of Medicine Clinical Trials Unit (DOM CTU). The positionsupports studies across disease areas, phases, and levels ofcomplexity, combining hands-on work with senior-level consultation,regulatory planning, and leadership of complex projects whenassigned. The manager independently performs and overseesregulatory activities, manages studies from intake throughclose-out, supervises and develops staff, and improves studyquality and operational effectiveness. Additional responsibilitiesinclude securing funded work for this position, pursuing work forother DOM CTU staff to support unit-wide sustainability, andcoordinating routine unit administration. Job Responsibilities The Regulatory/Project Manager C provides regulatory expertise andoversight, project management, and staff supervision for theDepartment of Medicine Clinical Trials Unit (DOM CTU). The positionsupports phase I-IV, investigator-initiated, and industry-sponsoredresearch across disease areas and levels of complexity.Responsibilities combine hands-on support and ongoing studymanagement with senior-level consultation and leadership of complexprojects when assigned. The position independently prepares and oversees regulatorysubmissions, documentation, and approvals; serves as a seniorregulatory resource; advises on regulatory approaches; and resolvescomplex compliance issues. Responsibilities includeaudit/inspection preparation and responses, corrective actions,regulatory SOPs and quality-review processes, and IND/IDE exemptionassessments and submissions when included in assignedservices. The manager leads study intake, feasibility, start-up,implementation, and close-out; develops project plans and studytools; and contributes to protocol and grant development, budgets,and resource planning. The position leads project teams, resolvesoperational barriers, develops performance metrics, and monitorsstudy quality, recruitment, scope, budgets, and deliverables. Themanager advises on resource deployment and implements improvementsacross assigned projects. The position directly supervises assigned research staff, includingwork assignment, workload and quality monitoring, onboarding,training, coaching, and performance evaluation. The managerparticipates in recruitment, addresses performance and developmentneeds, and promotes consistent use of SOPs, study tools, and bestpractices across assigned teams. Additional responsibilities include proactively marketing DOM CTUstaff and services, taking primary responsibility for securingfunded work to sustain this position, and sharing responsibilityfor pursuing and securing assignments for other CTU staff tosupport unit-wide financial sustainability. The manager alsocoordinates routine unit administration, performing or delegatingtasks while remaining accountable for timely completion. Qualifications Master's degree and 5-7 years of related clinical researchexperience, or an equivalent combination of education andexperience required. Progressively responsible experience inregulatory affairs, clinical research project management, and staffsupervision. Demonstrated ability to independently manage assignedstudies and regulatory work, coordinate multiple stakeholders, andsupervise, train, and evaluate staff. Demonstrated knowledge of IRB processes, human research protectionrequirements, Good Clinical Practice, and regulatory documentation.Strong written and verbal communication, planning, organization,problem solving, attention to detail, and follow-through. Abilityto manage competing priorities, anticipate and resolvestudy-related problems, maintain study quality, and meet deadlines.Proficiency with standard office, collaboration,andresearch-tracking tools. Preferred Experience in academic clinical research, SOP development, stafftraining, process improvement, and electronic regulatory documentsystems. A relevant master's degree or research/regulatorycertification is preferred. IND/IDE submission experience whenrelevant to assigned services, and experience communicatingresearch services and developing collaborations, arepreferred. Job Location - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $91,066.00 - $106,940.00 Annual Rate Salary offers are made based on the candidate's qualifications,experience, skills, and education as they directly relate to therequirements of the position, and in alignment with salary rangesbased on external market data for the job's level. Internalorganization 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), citizenshipstatus, age, disability, veteran status or any class protectedunder applicable federal, state or local law. Special Requirements Background checks may be required after a conditional job offer ismade. Consideration of the background check will be tailored to therequirements of the job. University Benefits Health, Life, and Flexible Spending Accounts : Pennoffers comprehensive medical, prescription, behavioral health,dental, vision, and life insurance benefits to protect you and yourfamily's health and welfare. You can also use flexible spendingaccounts to pay for eligible health care and dependent careexpenses with pre-tax dollars. Tuition : Take advantage of Penn's exceptional tuitionbenefits. You, your spouse, and your dependent children can gettuition assistance here at Penn. Your dependent children are alsoeligible for tuition assistance at other institutions. Retirement: Penn offers generous retirement plans tohelp you save for your future. Penn's Basic, Matching, andSupplemental retirement plans allow you to save for retirement on apre-tax or Roth basis. Choose from a wide variety of investmentoptions through TIAA and Vanguard. Time Away from Work: Penn provides you with asubstantial amount of time away from work during the course of theyear. This allows you to relax, take vacations, attend to personalaffairs, recover from illness or injury, spend time withfamily-whatever your personal needs may be. Long-Term Care Insurance: In partnership with GenworthFinancial, Penn offers faculty and staff (and your eligible familymembers) long-term care insurance to help you cover some of thecosts of long-term care services received at home, in the communityor in a nursing facility. If you apply when you're newly hired, youwon't have to provide proof of good health or be subject tounderwriting requirements. Eligible family members must alwaysprovide proof of good health and are subject to underwriting. Wellness and Work-life Resources : Penn is committed tosupporting our faculty and staff as they balance the competingdemands of work and personal life. That's why we offer a widevariety of programs and resources to help you care for your health,your family, and your work-life balance. Professional and Personal Development: Penn provides anarray of resources to help you advance yourself personally andprofessionally. University Resources: As a member of the Penn community,you have access to a wide range of University resources as well ascultural and recreational activities. Take advantage of theUniversity's libraries and athletic facilities, or visit ourarboretum and art galleries. There's always something going on atPenn, whether it's a new exhibit at the Penn Museum, the latestmusic or theater presentation at the Annenberg Center, or the PennRelays at Franklin Field to name just a few examples. As a memberof the Penn community, you're right in the middle of theexcitement-and you and your family can enjoy many of theseactivities for free. Discounts and Special Services : From arts andentertainment to transportation and mortgages, you'll find greatdeals for University faculty and staff. Not only do Penn arts andcultural centers and museums offer free and discounted admissionand memberships to faculty and staff. You can also enjoysubstantial savings on other goods and services such as new carsfrom Ford and General Motors, cellular phone service plans, movietickets, and admission to theme parks. Flexible Work Hours: Flexible work options offercreative approaches for completing work while promoting balancebetween work and personal commitments. These approaches involve useof non-traditional work hours, locations, and/or jobstructures. Penn Home Ownership Services: Penn offers a forgivableloan for eligible employees interested in buying a home orcurrently residing in West Philadelphia, which can be used forclosing costs or home improvements. Adoption Assistance: Penn will reimburse eligibleemployees on qualified expenses in connection with the legaladoption of an eligible child, such as travel or court fees, for upto two adoptions in your household. To learn more, please visit: Equal Employment 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), citizenshipstatus, age, disability, veteran status or any class protectedunder applicable federal, state, or local law. #J-18808-Ljbffr University of Pennsylvania