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 Program Lead

Job Profile Title

Clinical Research Program Manager C

Job Description Summary

This Clinical Research Program Lead position in the Penn Frontotemporal Degeneration Center (Penn FTDC) will directly oversee and manage day-to-day operations for federally-funded NIH and industry sponsored clinical research studies in the portfolio of PIs in the Penn FTDC.

The Clinical Research Program Lead will report directly to the co-director of the Penn FTDC and indirectly to the other co-directors and PIs within the Penn FTDC. He/she will directly supervise and lead clinical research teams of industry-supported clinical trial and federal observational research coordinators and project managers in the Penn FTDC, performing annual and ad hoc performance reviews, assist in interviewing clinical research and administrative staff and driving strategic initiatives for SOP development for clinical research operations in the Penn FTDC.

Job Description

He/She/They will oversee the start-to-end processes for clinical trial and observational study start-up, ongoing study management and project closeout. This includes assisting with study feasibility and selection, prioritization of the study team’s work, working closely with the study team and investigators to manage, review and initiate studies/trials to ensure competitive activation and enrollment timelines as well as facilitate timely study/trial closure. He/She will liaison with Office of Clinical Research (OCR) finance as well as other clinical teams at Penn to develop initial budgets for startup per protocol and be the point of contact for budget/payment correspondences with sponsor/NIH, OCR and Neurology Business office to track invoicing and payments received. The Clinical Research Program Lead will actively manage ongoing research projects, troubleshoot operational issues on a daily basis and assist with any and all aspects of their team’s work, including training on-boarding and maintaining team training with periodic inservice training sessions. He/She/They will also liaise with departments/stakeholders such as CHPS, Investigational Drug Services/Pharmacy, sponsors, CROs, Subcontractors, and Collaborators to support day to day operations for the FTDC. The Clinical Research Program Lead will ensure studies are conducted safely and in adherence with all applicable regulatory guidelines and supervise regulatory documentation including preparation of adverse event reporting, continuing reviews, protocol amendments and protocol startup/closeout and audits in cooperation with the Institutional Review Board.

Qualifications

• Bachelor's degree and 7-10 years of related experience or equivalent combination of education and experience is required. Master's degree and 5-7 years of experience preferred.

• Excellent verbal/written communication skills required

• Able to work collaboratively on all levels and to gain support of others

• Able to develop interdepartmental relationships and form solid collaborations

• Able to confidently interact with all levels of management including senior management, physician leaders and others

• Demonstrated complex problem solving abilities

• Strong innovative skills

• Excellent interpersonal and multi-tasking skills

• Must be flexible, detail oriented and organized

• Demonstrated ability to work as part of a team, as well as independently with minimal supervision

• Thorough knowledge relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines. Knowledge of funding policies, NIH, and other grant procedures is desired.)

  Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$74,476.00 - $106,940.00 Annual Rate

Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.

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.

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

  The University of Pennsylvania's special character is reflected in the diversity of the Penn community. We seek talented faculty and staff who will constitute a vibrant community that draws on the strength that comes with a substantive institutional commitment to diversity along dimensions of race, ethnicity, gender, sexual orientation, age, religion, disability, veteran status, interests, perspectives, and socioeconomic status. Grounded in equal opportunity, nondiscrimination, and affirmative action, Penn's robust commitment to diversity is fundamental to the University's mission of advancing knowledge, educating leaders for all sectors of society, and public service. The University of Pennsylvania prohibits unlawful discrimination based on 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.