Director of Clinical Research Operations
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Job Description Summary
The Director, Clinical Research Operations will report to the Chief Operating Officer of the Department of Neurology 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 Neurology. Initially the role will be focused on assessing the clinical research landscape in the Department of Neurology. Upon completion of assessment, the Director will develop and execute plans for a clinical research central structure within the Department of Neurology.
The Director will be engaged in every aspect of patient care as defined in study protocol(s), leading 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 the specific clinical protocol(s) as approved by the Sponsor, study team and in accordance with all regulatory organizations. The Director will engage and manage the performance of each Contract Research Organizations (CROs), and ensure that Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), regulatory guidelines, and all best practices are followed rigorously. The Director will work among senior leadership including the Study Sponsor, Program Directors, the CRO & Project Managers, and Clinical Operations staff, managing all clinical and operational aspects of each trial, allocating resources as needed. 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 related to establishing the budget required to meet trial goals and for the allocation of financial resources to assure that the clinical trial(s) is executed fully. The Director is also responsible for the development and implementation of innovative process ideas that impact clinical trials and/or clinical program management and to implement 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.
- Responsible for the design, development, implementation and maintenance of each clinical trial to ensure the allocation of fixed (personnel/space/equipment) and financial resources; establishing the risk mitigation plans to ensure that all clinical trials are conducted in accordance with the study protocol. Is responsible to assure clinical care and patient safety.
- Responsible for the development and preparation of clinical trial operational plans ensuring that clinical trials are conducted in a timely fashion and compliant with SOPs, GCP, and regulatory guidelines, company goals, and budgets; development and preparation of Clinical Protocols, assuring that Investigator’s Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs) are completed and followed.
- Negotiates, directs and executes the CRO and vendor selection process/agreement for outsourced activities, including development of scope of services agreements, plans, and timelines. Is authorized to terminate the CRO contract due to poor performance; negotiates, directs and executes the CRO and vendor agreements, ensuring that change orders and budgets meet clinical operations specifications. Is authorized to modify the allocation of resources in response to approved changes.
- Leads CRO strategic implementation committees, ensuring that performance expectations are met; leads the Medical Monitor and Clinical Operations program, approving those clinical investigators who will participate in a given trial.
- Develops and ensures that all study-related documents are compiled and completed as required. (e.g. Monitoring Plan, Study Reference Manual, Laboratory Manual, Pharmacy Manual, CRF Completion Guideline, among others); develops and ensures that all monitoring activities and processes are complete, including training of internal and external resources, and are compliant with SOPs and GCP/ICH/regulatory guidelines.
- Directs the development of clinical operations quality systems, including SOPs, document management, clinical operations personnel training, and quality control processes; remains actively engaged in organizational goals especially those directly related to all trials.
- Directs and manages clinical operations personnel, including hiring, training, coaching, performance reviews, and termination.
- Perform additional duties as assigned
- Combination of educational and work experience demonstrating competencies to perform the duties and responsibilities of the position
- Minimum of 15 years of experience in clinical care/clinical trials; thorough understanding of clinical processes (e.g. differential diagnosis), data management, biostatistics, and medical writing
- 10 years supervisory and management experience
- Strong knowledge in GCP and ICH and the application to the conduct of clinical trials
- Ability to clearly develop action plans to ensure delivery on company strategy and goals as well as clinical development plans
- Must be a demonstrated self-starter and team player with strong interpersonal skills
- Excellent written and verbal skills required
- Must display strong analytical and problem solving skills
- Attention to detail required
- Position requires the flexibility to travel.
- Master’s degree in biological science is required
- Ph.D. Preferred but not required
Job Location - City, State
Department / School
Perelman School of Medicine
$72,837.00 - $138,391.00
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.
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.