Clinical Research Program Manager - Hybrid
Cedars-Sinai · Beverly Hills, CA · Today
Project ManagementFull-time
About the role
This is an onsite position requiring a minimum of 4 days per week onsite. This role offers the opportunity to manage a disease-focused clinical research portfolio while leading a dedicated team supporting innovative, high-impact research. The ideal candidate will bring demonstrated program and people-management experience, including oversight of a disease-specific portfolio, resource prioritization, and clinical research team leadership, along with clinical research operations experience, preferably in an academic medical center setting.
Responsibilities
- Directs and manages a specified program within the clinical research operations unit, department, or division.
- Provides leadership, guidance, and direction for day-to-day clinical research operations and activities, including authority to make independent decisions regarding program operations, administration, and governance.
- Ensures compliant, efficient, and effective conduct of clinical trials within the portfolio.
- Establishes, implements, and evolves operational standards and monitors quality and progress of the program(s).
- Oversees and/or manages the assigned recognized organizational clinical research program, with authority for day-to-day operations and administration.
- May develop or expand the program; plans and implements operations; establishes governance, processes, and guidelines; coordinates activities and timelines; and organizes resources to meet objectives.
- May manage study intake, including feasibility, review and endorsement, PRMC submission, and tracking trials declined by program or department leadership.
- Identifies logistics, action items, changes, information needs, and barriers affecting study activation and coordination; participates in implementing solutions.
- May identify program participants and lead cross-functional teams supporting program administration, maintenance, or expansion.
- Collaborates with internal and external stakeholders, including departments, organizational leaders, and external agencies or organizations, to provide guidance, resolve issues, grow the program, and implement processes or solutions.
- Identifies growth and efficiency opportunities, supports strategic planning, manages study intake and feasibility, and provides recommendations or makes decisions supporting program success.
- Maintains program growth, community outreach, and stakeholder relationships.
- Researches and analyzes program performance, operations, quality assurance, and trends.
- Recommends or implements changes and provides findings to participants, stakeholders, leadership, and cross-functional teams.
- Provides clinical trial oversight, including screening, enrollment, data submission, protocol compliance, and staff training.
- Plans and supports department/program leaders during audits, including preparation and required follow-up.
- Evaluates requests for program exceptions or changes and determines responses, escalating as necessary.
- Assesses communication and training needs; develops and implements communication, education, training, onboarding, and mentorship activities.
- Provides regular updates to departments and organizational leaders, notifies stakeholders of program changes, and may develop materials with cross-functional teams.
- Partners with leadership to plan, monitor, and manage program budgets and financials and resolve or escalate issues.
- Maintains data system integrity and quality assurance in accordance with departmental standard operating procedures.
- May provide ad hoc reporting to support trend analysis, recommendations, planning, and enhancements.
- Monitors governance and compliance with local, state, and federal laws; accreditation, professional, and regulatory standards; licensure requirements; and organizational policies and procedures.
- Monitors compliance reporting tools and provides status reports to the Research Manager and other stakeholders.
- May manage staff and/or lead the work of others, including recruitment, onboarding/offboarding, training, performance management, and professional development.
Department-Specific Responsibilities
- Manages DRG meetings and ensures all information needed to support DRG functions is addressed.
- Communicates regularly with DRG faculty to ensure alignment with DRG needs and future planning.
- Engages relevant providers—including physicians, advanced practice providers, clinic nurses, and staff—to address clinical issues promptly and compliantly.
- Promotes and advances clinical research activities in a safe, compliant, effective, efficient, and collegial manner.
- Manages and oversees training and education for clinical research staff within the DRG/team.
- Conducts baseline competency assessments for new hires, identifies development opportunities, and creates training plans following onboarding.
- Provides ongoing staff development and competency assessments.
- Contributes to the development and execution of educational in-services supporting high-quality clinical research.
- Contributes to corrective action plans and monitors implementation and documentation of progress.
- Ensures compliance with Cedars-Sinai, CCTO, and SOCCI policies and procedures.
- Actively participates in SOCCI’s strategic planning process for the Cancer Clinical Trials Office.
- Represents the Clinical Trials Office on University/Hospital committees and task forces as assigned.
Qualifications
- Required High School Diploma/GED
- 5 years of management, program management, project management, or related experience
- 3 years of related experience in the area of specialization within clinical research or an industry setting
- Preferred Bachelor’s Degree in Healthcare, Management, or a related field
- 1 year of experience managing the operations of a clinical trial