Clinical Research Project Manager C

Upenn; Philadelphia (Philadelphia County); Presencial; USD 91.000 - 107.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Tuition benefits

Retirement plans

Wellness programs

Descripción de la vacante

University of Pennsylvania in Philadelphia seeks a Regulatory/Project Manager C to provide regulatory expertise and oversight for the Department of Medicine Clinical Trials Unit. You will manage regulatory submissions, lead project teams, and supervise staff across trials from intake to close-out.

Requirements include a Master’s degree and 5–7 years in regulatory affairs and clinical research project management. Strong communication and organizational skills are essential.

Formación

• Master's degree and 5-7 years of related clinical research experience, or an equivalent combination of education and experience required.
• Progressively responsible experience in regulatory affairs, clinical research project management, and staff supervision.
• Knowledge of IRB processes, human research protection requirements, GCP, and regulatory documentation.

Responsabilidades

• Prepare and oversee regulatory submissions, documentation, and approvals; serve as a senior regulatory resource.
• Lead study intake, feasibility, start-up, implementation, and close-out; develop project plans and study tools.
• Supervise assigned research staff, provide training, and evaluate performance.

Conocimientos

Regulatory affairs

Clinical research PM

Staff supervision

IRB processes

Regulatory documentation

Educación

Master's degree

Herramientas

Office tools

Descripción del empleo

## Clinical Research Project Manager CApply: HUP: Full time: Posted Today: JR00129420**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 C**Job Profile Title**Clinical Research Project Manager C**Job Description Summary**The Department of Medicine Clinical Trials Unit (DOM CTU) 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. 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/. The Regulatory/Project Manager C provides regulatory expertise and oversight, project management, and staff supervision for the Department of Medicine Clinical Trials Unit (DOM CTU). The position supports studies across disease areas, phases, and levels of complexity, combining hands-on work with senior-level consultation, regulatory planning, and leadership of complex projects when assigned. The manager independently performs and oversees regulatory activities, manages studies from intake through close-out, supervises and develops staff, and improves study quality and operational effectiveness. Additional responsibilities include securing funded work for this position, pursuing work for other DOM CTU staff to support unit-wide sustainability, and coordinating routine unit administration.**Job Description****Job Responsibilities**The Regulatory/Project Manager C provides regulatory expertise and oversight, project management, and staff supervision for the Department of Medicine Clinical Trials Unit (DOM CTU). The position supports phase I-IV, investigator-initiated, and industry-sponsored research across disease areas and levels of complexity. Responsibilities combine hands-on support and ongoing study management with senior-level consultation and leadership of complex projects when assigned.The position independently prepares and oversees regulatory submissions, documentation, and approvals; serves as a senior regulatory resource; advises on regulatory approaches; and resolves complex compliance issues. Responsibilities include audit/inspection preparation and responses, corrective actions, regulatory SOPs and quality-review processes, and IND/IDE exemption assessments and submissions when included in assigned services.The manager leads study intake, feasibility, start-up, implementation, and close-out; develops project plans and study tools; and contributes to protocol and grant development, budgets, and resource planning. The position leads project teams, resolves operational barriers, develops performance metrics, and monitors study quality, recruitment, scope, budgets, and deliverables. The manager advises on resource deployment and implements improvements across assigned projects.The position directly supervises assigned research staff, including work assignment, workload and quality monitoring, onboarding, training, coaching, and performance evaluation. The manager participates in recruitment, addresses performance and development needs, and promotes consistent use of SOPs, study tools, and best practices across assigned teams.Additional responsibilities include proactively marketing DOM CTU staff and services, taking primary responsibility for securing funded work to sustain this position, and sharing responsibility for pursuing and securing assignments for other CTU staff to support unit-wide financial sustainability. The manager also coordinates routine unit administration, performing or delegating tasks while remaining accountable for timely completion. **Qualifications**Master's degree and 5-7 years of related clinical research experience, or an equivalent combination of education and experience required. Progressively responsible experience in regulatory affairs, clinical research project management, and staff supervision. Demonstrated ability to independently manage assigned studies and regulatory work, coordinate multiple stakeholders, and supervise, train, and evaluate staff.Demonstrated knowledge of IRB processes, human research protection requirements, Good Clinical Practice, and regulatory documentation. Strong written and verbal communication, planning, organization, problem solving, attention to detail, and follow-through. Ability to manage competing priorities, anticipate and resolve study-related problems, maintain study quality, and meet deadlines. Proficiency with standard office, collaboration, and research-tracking tools.**Preferred**Experience in academic clinical research, SOP development, staff training, process improvement, and electronic regulatory document systems. A relevant master’s degree or research/regulatory certification is preferred. IND/IDE submission experience when relevant to assigned services, and experience communicating research services and developing collaborations, are preferred.**Job Location - City, State**Philadelphia, Pennsylvania**Department / School**Perelman School of Medicine**Pay Range**$91,066.00 - $106,940.00 Annual RateSalary 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.**University Benefits*** **Health, Life, and Flexible Spending Accounts**: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.* **Tuition**: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.* **Retirement:** Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.* **Time Away from Work:** Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.* **Long-Term Care Insurance:** In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.* **Wellness and Work-life Resources**: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.* **Professional and Personal Development:** Penn provides an array of resources to help you advance yourself personally and professionally.* **University Resources:** As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.* **Discounts and Special Services**: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.* **Flexible Work Hours:** Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.* **Penn Home Ownership Services:** Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.* **Adoption Assistance:** Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.*To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay*