Director, Clinical Research Operations

Director, Clinical Research Operations

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. 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.

The Director, Clinical Research Operations will report to the Director of Fiscal Operations of the Department of Radiology Research with a dotted line reporting to the Vice Chair of Clinical Research. The Director, Clinical Research Operations is responsible to ensure that translation of science is achieved by managing clinical trials with investigators within the Department of Radiology. Initially the role will be focused on assessing the clinical research landscape in the Department of Radiology. Upon completion of assessment, the Director will develop and execute plans for a clinical research central structure within the Department of Radiology. The Director will lead Operations teams prior and subsequent to trial execution. Additionally, the Director will manage / supervise the clinical and administrative personnel, assuring that each clinical trial meets patient care expectations and that they are conducted in accordance with clinical protocol(s) as approved and in accordance with all regulatory organizations. The Director will ensure that Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), regulatory guidelines, and all best practices are followed rigorously. The Director will supervise the allocation of resources to facilitate clinical and operational aspects of trials. Central to the position is meeting all reporting requirements of all external review organizations, most notably the Food and Drug Administration (FDA). In addition to clinical trial management, the Director is responsible for working with the Managers of Clinical Research Finance Operations to establish the budget required to meet trial goals and to allocate the financial resources needed to assure that each clinical trial is executed fully. The Director is also responsible for the development and implementation of innovative process ideas that impact clinical trials management and for the implementation of clinical operations quality systems, document management, and quality control processes. At all times the Director is expected to remain actively engaged in organizational goals with particular focus on departmental program goals and objectives.

The Director, Clinical Research Operations will report to the Director of Fiscal Operations of the Department of Radiology Research with a dotted line reporting to the Vice Chair of Clinical Research. The Director, Clinical Research Operations is responsible to ensure that translation of science is achieved by managing clinical trials with investigators within the Department of Radiology. Initially the role will be focused on assessing the clinical research landscape in the Department of Radiology. Upon completion of assessment, the Director will develop and execute plans for a clinical research central structure within the Department of Radiology.

The Director will lead Operations teams prior and subsequent to trial execution. Additionally, the Director will manage / supervise the clinical and administrative personnel, assuring that each clinical trial meets patient care expectations and that they are conducted in accordance with clinical protocol(s) as approved and in accordance with all regulatory organizations. The Director will ensure that Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), regulatory guidelines, and all best practices are followed rigorously. The Director will supervise the allocation of resources to facilitate clinical and operational aspects of trials. Central to the position is meeting all reporting requirements of all external review organizations, most notably the Food and Drug Administration (FDA).

In addition to clinical trial management, the Director is responsible for working with the Managers of Clinical Research Finance Operations to establish the budget required to meet trial goals and to allocate the financial resources needed to assure that each clinical trial is executed fully. The Director is also responsible for the development and implementation of innovative process ideas that impact clinical trials management and for the implementation of clinical operations quality systems, document management, and quality control processes. At all times the Director is expected to remain actively engaged in organizational goals with particular focus on departmental program goals and objectives.

Perform other duties and responsibilities as assigned.

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

Philadelphia, Pennsylvania

Perelman School of Medicine

$124,500.00 - $124,500.00 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.

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.

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 familywhatever 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.
• 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 excitementand 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.