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Open nowPosted 22 days ago

Director, Study Operations

P954 open roles

Where
USA, United States
Work mode
Remote
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Your applicationOpen nowDirector, Study OperationsP95 · USA, United States

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The clock on this job

Early applications get read.

11.5% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.0%1 day
  2. 4.3%3 days
  3. 11.5%7 days
  4. 18.1%14 days
  5. 35.6%30 days
  6. 44.6%60 days
This job: posted 22 days ago

The posting

Job description

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.

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

Job benefits

  • 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
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