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Director, Clinical Operations

Company: Beaufort
Location: Norfolk
Posted on: September 13, 2020

Job Description:

Beaufort CRO is currently looking to hire a full-time  Director, Clinical Operations ,with experience managing Diagnostic Clinical and Regulatory 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.

Responsibilities 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.

Qualifications A minimum of 8-10 years of clinical development experience at the managerial/director level

Bachelors degree required, Master's degree or higher level education preferred.

Experience with in-vitro diagnostic clinical trials is required.

At least 3 years of direct managerial and employee supervision experience required.

Ability to wear ‘many hats’ and impact growth of a department.

Ability to manage multiple conflicting priorities and varied concurrent tasks.

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Keywords: Beaufort, Norfolk , Director, Clinical Operations, Other , Norfolk, Virginia

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