About the role
P95 Julius Clinical is a leading global, full-service Clinical Research Organization (CRO) delivering integrated clinical development and real-world evidence solutions across five continents. Formed through the strategic merger of P95 and Julius Clinical, the organization combines P95's leadership in infectious diseases, vaccines, and real-world evidence with Julius Clinical's expertise in central nervous system, cardio-metabolic, renal, and rare diseases, creating a unique mid-sized CRO with scale, agility and scientific depth. We operate with a team of 500 professionals and a track record that includes more than 1000 clinical trials conducted in over 50 countries. We offer comprehensive CRO capabilities supporting both full-service and modular approaches across the entire development lifecycle and post-marketing phases for pharmaceutical, biotech, and public health partners.
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
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.
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
Originally posted on Himalayas