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
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
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
Provide direction and leadership in vendor selection and
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
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
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
Experience with in-vitro diagnostic clinical trials is
At least 3 years of direct managerial and employee supervision
Ability to wear ‘many hats’ and impact growth of a
Ability to manage multiple conflicting priorities and varied
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