Clinical Research Program Manager, Hybrid
About The Position
The Clinical Research Program Manager directs and manages a specified program within a clinical research operations unit, department, or division. The role provides leadership and guidance for daily operations and activities, with authority to make independent decisions about program operations, administration, and governance. It ensures clinical trials in the portfolio are conducted compliantly and efficiently, establishes and evolves operational standards, and monitors program quality and progress. The program is an ongoing organizational initiative with defined objectives and scope but no defined end date. The position manages a disease-focused clinical research portfolio and leads a dedicated team supporting high-impact research. It oversees program planning, governance, processes, resources, study intake and feasibility, stakeholder relationships, quality assurance, compliance, budgets, communications, training, and staff development. Department-specific duties include managing DRG meetings, coordinating with DRG faculty and clinical providers, supporting staff competency and education, advancing compliant research activities, and contributing to SOCCI strategic planning. The role is onsite at least four days per week.
Requirements
- High school diploma or GED.
- Five years of management, program management, project management, or related experience.
- Three 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.
- One year of experience managing the operations of a clinical trial.
Responsibilities
- Oversee and manage the assigned organizational clinical research program, including day-to-day operations, administration, planning, governance, processes, guidelines, timelines, and resources.
- Manage study intake and feasibility, which may include review and endorsement, PRMC submission, and tracking trials declined by program or department leadership.
- Identify logistics, action items, changes, information needs, and barriers 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, maintain community outreach and stakeholder relationships, and make or recommend decisions supporting program success.
- Analyze program performance, operations, quality assurance, and trends; recommend or implement changes and report findings to stakeholders and leadership.
- Provide clinical trial oversight, including screening, enrollment, data submission, protocol compliance, and staff training.
- Plan and support department or program leaders during audits, including preparation and follow-up.
- Evaluate requests for program exceptions or changes and determine responses, escalating as necessary.
- Assess communication and training needs; develop and implement communications, education, training, onboarding, and mentorship activities.
- Provide program updates, notify stakeholders of changes, and develop materials with cross-functional teams as needed.
- 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.
- May manage staff or lead the work of others, including recruitment, onboarding and offboarding, training, performance management, and professional development.
- Manage DRG meetings and ensure required information is addressed.
- Communicate regularly with DRG faculty to align with DRG needs and future planning, and engage relevant providers to address clinical issues promptly and compliantly.
- Promote clinical research activities in a safe, compliant, effective, efficient, and collegial manner.
- Manage and oversee clinical research staff training and education; conduct baseline competency assessments for new hires, identify development opportunities, create onboarding training plans, and provide ongoing development and assessments.
- 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 strategic planning for the Cancer Clinical Trials Office.
- Represent the Clinical Trials Office on University or Hospital committees and task forces as assigned.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
High school or GED
