"Director, Clinical Research Operations"

Job Description Summary

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.

Job Responsibilities

• 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.

Position is Contingent Upon Grant Funding

Qualifications

• 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.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$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.