Senior Consultant | Regulatory Affairs & Quality Assurance | United States
Our client are looking for a Director of Clinical who has hands-on industry experience in both Clinical Affairs & Clinical Services for their high-risk Medical Device & IVD CRO.
Duties
Direct and coordinate CRO Services activities, ensuring clinical projects meet endpoints.
Collaborate with Regulatory colleagues for compliance in regulatory submissions.
Develop operational strategy for assigned projects, overseeing timeline and financials.
Lead operational delivery of clinical studies, ensuring quality and inspection readiness.
Manage and mentor CRO Services staff, including recruitment and performance management.
Assist in client meetings, project scoping, and resource requirements for proposals.
Provide expertise in clinical strategy and study operations for timely, high-quality outcomes.
Ensure client satisfaction and implement systems for continuous improvement.
Experience
10+ years of Medical Device & IVD Clinical experience
Previous management experience
Previous strategic & continuous improvement position
Experienced working in a CRO
Worked on data Management
thomas.hatfield@acepartners.co.uk
Seniority level
Director
Employment type
Full-time
Job function
Consulting
Industries
Medical Equipment Manufacturing
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