Clinical Research Program Manager

Clinical Research Program Manager

Working in partnership with the Director of Clinical Research of the Center for Cytokine Storm Treatment and Laboratory (CSTL), the Program Manager oversees all Castleman disease (CD) clinical research programs, specifically including the CD ACCELERATE natural history registry and CD biobank, Castlebank. The Program Manager will be key to the strategic planning and establishment of the CSTL, which will integrate clinical, research, educational and patient advocacy operations. The Program Manager will be engaged in the oversight of data acquisition and research execution of the ACCELERATE natural history registry and biobank studies.

The Program Manager will ensure that the protocols, SOPs, regulatory guidelines, GCP, and all best practices are followed rigorously. The Program manager will work closely with major internal (PI, data coordinators, researcher, laboratory technician, students, Institutional Review Board (IRB), etc.) and external (pharmaceutical collaborators, non-profit partners, external collaborators, oversight boards, CROs, Subcontractors, etc.) stakeholders to ensure regulatory compliance, completion of project milestones, and completion of all reporting requirements, and correct allocation of resources.

Strategic planning and oversight by the Program Manager will be critical to the successful establishment of the ACCELERATE Natural History Registry and Castlebank. It is essential that the Program Manager has experience with research planning, operations, and project management. Another important component of the Program Manager is managing oversight of a clinical trial, which includes assisting with recruitment, patient visits, blood draws, documentation, data entry, and IRB submissions. They will directly manage the research team (2 data analysts whose hiring is expected plus part-time and student workers, one registry coordinator, and one biobank assistant).

This position will also participate in the quality auditing and database management of ACCELERATE and Biobank studies. The Program Manager will also manage the database, perform quality auditing and adverse event reporting, and work with the UPenn IRB and foreign Ethics Committees in accordance with protocol requirements. The Program Manager will coordinate the preparation and submission of regulatory documents (including continuing reviews, amendments, and adverse event reporting) to the IRB and other regulatory institutions. They will help with the orientation, training and supervision of data analysts, coordinators, and student workers.

***Position contingent to funding***

Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is required. Master's degree in a health-related discipline plus 3-5 years relevant clinical research experience preferred. Hematology/oncology, immunology, clinical trial, and registry study experience is preferred.

Strong organizational skills; experience conducting studies in one or more of the above content areas preferred; excellent verbal and written communication skills essential to enable working with multiple members of research team; must be highly skilled in MS Word and Excel applications, understand medical records/patient charts organization and terminology. Strong management and leadership skills essential. Additional experience in clinical research is a plus. The appropriate candidate will possess a thorough knowledge of Federal Regulations, GCP and IND/IDE in research. Must understand regulatory affairs and their applications to Quality Control and Quality Assurance; understand the application of federal, local and institutional regulations as they apply to the conduct of human subjects research. Position requires effective problem solving abilities; must be able to multi-task and prioritize; a strong work ethic; ability to work as part of a team, as well as independently; and excellent organizational and time management skills. Demonstrated ability to effectively present complex information is required.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$75,804.00 - $81,441.00 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.

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.