Clinical Research Program Manager, Hybrid

Cedars-Sinai Medical Center•Beverly Hills, CA

2d•Onsite

About The Position

The Clinical Research Program Manager directs and manages a specified program within the clinical research operations unit, department, or division. The role provides leadership and guidance for day-to-day clinical research operations, with authority to make independent decisions regarding program operations, administration, and governance. The manager ensures trials within the portfolio are conducted compliantly and effectively, establishes and evolves operational standards, and monitors program quality and progress. The position manages a disease-focused clinical research portfolio and leads a dedicated team supporting research. It may involve developing or expanding the program; establishing governance and processes; coordinating activities, timelines, and resources; managing study intake and feasibility; and working with internal and external stakeholders. The manager analyzes performance, operations, quality, and trends; supports audits, training, communications, budgets, and compliance; and may manage staff or lead the work of others. Department-specific work includes managing DRG meetings and faculty communication, engaging providers to address clinical issues, overseeing staff education and competency development, contributing to corrective action plans and strategic planning, and representing the Clinical Trials Office on assigned committees and task forces. This is an onsite position requiring a minimum of four days per week onsite.

Requirements

High School Diploma or 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.

Nice To Haves

Bachelor’s Degree in Healthcare, Management, or a related field.
1 year of experience managing the operations of a clinical trial.

Responsibilities

Oversee and/or manage the assigned recognized organizational clinical research program, including day-to-day operations and administration.
Develop or expand the program; plan and implement operations; establish governance, processes, and guidelines; coordinate activities and timelines; and organize resources.
Manage study intake, including feasibility, review and endorsement, PRMC submission, and tracking trials declined by program or department leadership.
Identify barriers and information needs affecting study activation and coordination, and participate in implementing solutions.
Identify program participants and lead cross-functional teams supporting program administration, maintenance, or expansion.
Collaborate with internal and external stakeholders to provide guidance, resolve issues, grow the program, and implement processes or solutions.
Identify growth and efficiency opportunities, support strategic planning, manage study intake and feasibility, and provide recommendations or make decisions supporting program success.
Maintain program growth, community outreach, and stakeholder relationships.
Research and analyze program performance, operations, quality assurance, and trends; recommend or implement changes and communicate findings.
Provide clinical trial oversight, including screening, enrollment, data submission, protocol compliance, and staff training.
Plan and support audits, including preparation and required follow-up.
Evaluate requests for program exceptions or changes and determine responses, escalating as necessary.
Assess communication and training needs; develop and implement communication, education, training, onboarding, and mentorship activities.
Provide regular updates to departments and organizational leaders and notify stakeholders of program changes.
Partner with leadership to plan, monitor, and manage program budgets and financials and resolve or escalate issues.
Maintain data system integrity and quality assurance in accordance with departmental standard operating procedures; provide ad hoc reporting as needed.
Monitor governance and compliance with applicable laws, standards, licensure requirements, and organizational policies and procedures.
Monitor compliance reporting tools and provide 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.
Manage DRG meetings and ensure information needed to support DRG functions is addressed.
Communicate regularly with DRG faculty to ensure alignment with DRG needs and future planning.
Engage physicians, advanced practice providers, clinic nurses, and staff to address clinical issues promptly and compliantly.
Promote and advance clinical research activities in a safe, compliant, effective, efficient, and collegial manner.
Manage and oversee training and education for clinical research staff within the DRG/team.
Conduct baseline competency assessments for new hires, identify development opportunities, and create training plans following onboarding.
Provide ongoing staff development and competency assessments, and contribute to educational in-services supporting high-quality clinical research.
Contribute to corrective action plans and monitor implementation and documentation of progress.
Ensure compliance with Cedars-Sinai, CCTO, and SOCCI policies and procedures.
Participate in SOCCI’s strategic planning process for the Cancer Clinical Trials Office.
Represent the Clinical Trials Office on University/Hospital committees and task forces as assigned.
Perform other duties as assigned.