The Ohio State University's Clinical and Translational Science Institute is seeking a Senior Director to lead the establishment, strategic development, and operation of a new multisite clinical trials coordinating center (MTCC).
Requirements
- Demonstrated experience in multisite clinical trial coordination and regulatory compliance.
- Strong knowledge of clinical trial operations, data management systems, and GCP.
- Experience launching or managing a clinical trial coordinating center or similar infrastructure.
- Familiarity with NIH-funded research, academic medical centers, and federal grant mechanisms.
- Certification in clinical research (e.g., ACRP, SOCRA) is strongly preferred.
Responsibilities
- Lead the planning, launch, and operationalization of the Clinical and Data Coordinating Center.
- Develop and implement strategic goals, policies, and procedures for the center.
- Oversee the coordination of multisite clinical trials, including protocol development, site management, and data oversight.
- Ensure compliance with federal regulations (FDA, NIH, OHRP), GCP, and institutional policies.
- Establish systems for trial tracking, quality assurance, and performance metrics.
- Guide the development of data coordination infrastructure, including EDC systems, data quality monitoring, and reporting tools.
- Collaborate with biostatisticians and informatics teams to ensure robust data governance and deliverables are being met.
Other
- Bachelor's degree in biomedical sciences, health sciences, social sciences or other medical field or equivalent experience required.
- Minimum 7–10 years of experience in clinical research, with at least 3 years in a leadership or management role.
- Proven ability to build and lead teams, manage complex projects, and work across disciplines.
- Excellent communication, organizational, and strategic planning skills.
- Master’s degree or higher in a health-related field (e.g., MPH, MS, PharmD, PhD, MD, or equivalent).
