Director, Study Operations

The Role
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.

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

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