Beaufort CRO is currently looking to hire a full-time Director of Clinical Operations, with experience managing Diagnostic Clinical and Medical Affairs study/project teams. Reporting to the VP, Clinical Operations, the successful candidate will oversee diagnostic clinical study teams, represent the clinical operations department, and will be responsible for direct oversight of team members. The Director, Clinical Operations is responsible for operational leadership and successful execution of clinical trials according to regulatory guidelines and must facilitate effective internal and external relationships. The Director, Clinical Operations is responsible for the achievement of project goals and objectives on time and on budget, as well as being responsible for staff and financial management.
This position can either be located in Norfolk, VA, or can be performed remotely based on the preference of the candidate. This is a full- time salaried (W-2) position with excellent benefits provided.
- Contribute to strategic planning to ensure optimized clinical development plans for assigned projects.
- Manage In-Vitro Diagnostic clinical trial project teams.
- Provide direction and mentor staff including setting goals that are aligned with both Corporate and project goals.
- Building, managing, and maintaining high performing clinical teams.
- Provide direction and leadership in vendor selection and management.
- Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
- Partner with Clinical Development, Biostatistics, Data Management, Finance, Project Management and Regulatory, to ensure operational excellence.
- Be responsible for and manage clinical research activity, Director(s), Clinical Project Managers, Contract CRAs, data management, CTAs, etc.
- Prepare clinical research budgets, timelines and support development teams in scenario planning/costing.
- Approve clinical monitoring plans and prioritize study monitoring needs.
- Analyze and develop action plans to address issues with investigational sites, CRAs, etc.
- Influence development team thinking to enable high quality, operationally feasible clinical trial protocols and plans.