Senior Manager

Company: Cedars-Sinai
Location: Los Angeles
Posted on: March 20, 2023

Job Description:

The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all of our patients with cancer! Join our team and contribute to groundbreaking research! The Senior Manager of The Angeles Clinic and Research Institute (TACRI) Clinical Research Office (CRO) provides strategic leadership to the clinical, regulatory, and financial units of the TACRI CRO. Directs managers/supervisors assigned to these units within the CRO by establishing and implementing operational standards and supervising progress and compliance. Serves as the subject matter expert on standard methodologies on clinical trial management, regulatory requirements. Accountable for the strategic growth and continued success of the TACRI CRO, in collaboration with the Executive Director for TACRI's CRO and CRO Medical Director. Works collaboratively to develop, implement, and maintain the infrastructure necessary to support National Cancer Institute (NCI) designation. Primary Duties and Responsibilities:

• Responsible for the strategic planning, organizing, and oversight of the TACRI CRO including the development of strategies for patient recruitment, compliance, performance and quality improvement, operational efficiency, and employee engagement.
• Ensures the development of TACRI's clinical research infrastructure that supports the clinical research community and is consistent with expectations of NCI-designated Cancer Centers as outlined in the Cancer Center Support Grant (CCSG) guidelines. Ensures that all institutional, local, state, and Federal Regulations, Good Clinical Practice (GCPs), ICH, and IRB requirements are met and that all research programs within TACRI are structured to continue to meet these expectations.
• Supervises a team of highly skilled and efficient clinical research staff charged with upholding the same expectations and requirements including continued focus on increasing efficiencies, improving quality control, and providing a robust training and education program. Provides expertise, guidance, and oversight to the operational units within the CRO (clinical, regulatory, finance, quality, training, information systems, etc.)
• Supports the implementation and/or maintenance of requirements as outlined in the National Cancer Institute's, Cancer Center Support Grant guidelines relative to all clinical research requirements (i.e. Clinical Protocol and Data Management, Accrual of Women and Minorities to clinical trials and associated Data Tables);
• Supervises the development, implementation, and updating of standard operating procedures (SOPs) to ensure consistent, safe, and efficient management of clinical trials and continuous improvements in the fiscal integrity of clinical research activities.
• Administrative management of the electronic systems used to supervise CRO performance and efficiency and participation in the development or the selection of institutional systems that would impact the CRO operations and conduct of clinical research in TACRI.
• Provides oversight for generation of monthly reports including but not limited to CRO performance, accrual, monitoring, time to activation, audit visits, and financial performance. Ensure accuracy of clinical trial information in all CTMS, clinical trial databases, and tracking systems. Ensure quality, timely, and accurate data and report submission;
• Supports the expansion of TACRI clinical research program across Cedars-Sinai Cancer Network and Affiliate sites in conjunction with institutional leadership.
• Integration of Cedars-Sinai and the TACRI central research administration initiatives and serve as a pilot for expanding clinical research support services enterprise-wide as appropriate;
• Supervises financial resources, development, and management of clinical trials budgets; and in conjunction with the Executive Director of the CRO and TACRI Finance Director prepare, supervise, and forecast the CRO annual operations budget;
• Supervises employees, including responsibility for determining qualifications, hiring, maintaining and improving competence, assigning work, evaluating performance, compensation, discipline and terminating employment.
• Serves as an effective leader by maintaining a positive work climate and promoting an environment that fosters self-directed staff, assists employee to develop and contribute to the organization and applies human resources resource policies fairly and consistently. Educational Requirements:
  • Bachelor's Degree (Minimum)
  • Master's Degree - Science or related field (Preferred)
  • Licenses: Cert Clin Research Professional (Upon Hire-Minimum) Experience:
    • 5 years Clinical research experience
    • 4 years Managerial level experience. Evidence of progressive leadership experience
    • 4 years Knowledge and/or experience with NCI CCSG expectations is preferred
    • 4 years Previous experience coordinating and leading oncology clinical research programs

Keywords: Cedars-Sinai, Los Angeles , Senior Manager, Executive , Los Angeles, California