Clinical Research Project Manager

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

The Project Manager will provide staff oversight, project management, expertise, and administrative
support for clinical trials in the Penn Infectious Diseases Clinical Research Unit consisting of projects in HIV, COVID-19, and other
infectious diseases. Project Manager work includes overall management of research projects, supervision of research staff, regulatory
submissions, recruitment strategy, study start-up, performance management, and development of key study documents including
protocol, consent, and CRFs. The Project Manager will oversee expenditures and income, negotiate agreements with service
providers, and interact with the business administration to ensure income is received and expenditures are paid. The position will also
include participation in national organization meetings, as well as University department meetings and committees. The staff member
will maintain skill levels through educational opportunities, sponsor trainings, attendance at conferences and communication with
other providers.

Job Description

With supervision, manage research studies conducted through the ACTU Clinical Trials Unit in accordance with Good Clinical Practice guidelines and all applicable regulatory guidelines.

Conduct study related visits and procedures, including recruitment, when needed to meet the needs of Research Projects.

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.

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

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.

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.

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.

Perform other duties as needed

Contingent upon funding

The Project Manager will provide project management and regulatory support and expertise associated with clinical trials for the Penn Department of Medicine Infectious Disease Clinical Trials Unit. The person will work closely with leadership to support investigators and coordinators, working on observational clinical research and 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.

The 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.

Position requires up to full time on-site work to manage staff and projects, with possibility for 1 day per week remote work.

Qualifications

• Bachelor's Degree with 3-5 years of related experience or equivalent combination of education and experience is required.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$63,085.00 - $78,231.00 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 protectedunder 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.

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To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay