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Medical University of South Carolina - Charleston, SC
posted 2 months ago
About the position
The Research Study Team Program Manager at Hollings Cancer Center is responsible for overseeing the activation and management of clinical trials within the Disease Focus Groups (DFG). This role includes HR oversight of the clinical operations team, ensuring timely study activation, achieving accrual goals, and supporting strategic initiatives within the Clinical Trials Office (CTO). The Program Manager will manage a team of study coordinators and data managers, ensuring compliance with regulations and effective training and mentorship of staff.
Responsibilities
- Oversee the clinical trials start-up for CTO managed clinical trials within the DFG.
- Manage adherence to clinical trial start-up tasks and timelines.
- Review new interventional protocols for feasibility and collaborate with the Resource Allocation and Feasibility Team (RAFT).
- Collaborate with the Regulatory PM1 to set task list targets and ensure PI availability for meetings.
- Work with the Pre-Award Fiscal Lead to ensure accurate budget and coverage analysis for trials.
- Oversee the completion of draft roadmaps and lab processing forms by study coordinators.
- Manage HR responsibilities including recruitment, hiring, and evaluation of clinical operations staff.
- Mentor and train clinical operations staff to improve skills and performance.
- Oversee clinical trials portfolio management, focusing on activation times, accrual rates, and protocol compliance.
- Facilitate DFG meetings and support decision-making for trial prioritization and resource allocation.
- Assess employee workload and propose staffing plans to meet trial performance needs.
Requirements
- A bachelor's degree in a relevant field.
- Three years of relevant program experience.
Nice-to-haves
- Experience in clinical trial management.
- Knowledge of ICH Good Clinical Practice Guidelines.
- Strong leadership and mentorship skills.
Benefits
- Health insurance
- Dental insurance
- 401k retirement plan
- Paid holidays
- Professional development opportunities
