About The Position
This is a senior operational leadership role with end-to-end accountability for the performance, quality, development and budget of the Study Operations function across North America (CRAs, CTA, Leads, etc). They will set the strategic direction for study set-up and delivery in the region, act as the senior escalation point for complex operational issues, and represent Study Operations in cross-functional forums, client interactions and senior internal governance. This is a role for an experienced clinical ops leader within a CRO environment who is able to shape departmental strategy, inspire other managers, and coach teams through the realities of multinational trial delivery.
Requirements
- 10 years of progressive experience in life sciences, including at least 7 years in clinical operations and people management within a CRO environment
- Extensive experience managing multinational clinical trials
- Demonstrable track record of regional team leadership with budget accountability
- Proven line management of CRAs, CTAs and/or CTLs, including management of managers where regional scale requires it
- Academic degree in biomedical sciences or a related life sciences field
- Excellent knowledge of ICH-GCP guidelines and applicable regulatory requirements
- Strong command of the operational aspects of clinical trial set-up and management
- Extensive experience with the development of clinical protocols, policies and SOPs
- Demonstrated experience of budget planning and expenditure management
Responsibilities
- Full accountability for the coordination, management and performance of the US Study Operations team across all staff levels and locations
- Ownership of the regional budget, including resource planning, expenditure management and forecasting
- Responsibility for the technical and managerial leadership and organizational development of the regional team
- Provide strategic direction on all operational aspects of study set-up and delivery within the region
- Monitor team performance, workload allocation and capacity; identify and resolve conflicts
- Represent Study Operations regionally in cross-functional forums, client interactions and senior internal governance
- Provide input to study proposals and commercial planning for the region
- Lead performance management, goal setting and development planning across the regional teams
- Evaluate and stimulate the performance and development of all Study Ops staff in the region
- Lead the establishment and continuous improvement of departmental processes; drive adoption across the region and alignment to company standards
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What This Job Offers
Job Type
Full-time
Career Level
Senior
