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Director, Country Operations Management

Director, Country Operations Management

AstraZenecaBoston, MA, US
Hace 26 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

Director, Country Operations Management (DCOM)

Location : Boston, Seaport

Hybrid : 60% onsite

The Director, Country Operations Management (DCOM) is a member of the local study delivery leadership team accountable for execution of interventional Phase 2 and 3 clinical trials within an assigned Therapy Area. This role is fully accountable for delivering all operational trial milestoneson time, with quality, and in compliance with ICH-GCP, SOPs, and US regulations.

This role combines strategic project leadership with direct line management of a team of 810, ensuring optimized resource planning, cross-functional collaboration, and high team performance across complex clinical programs. This role offers the opportunity to lead impactful clinical programs while developing and empowering a team of clinical professionals. The DCOM plays a critical role in local study delivery, ensuring excellence in both people leadership and operational delivery.

Key Responsibilities

People Leadership & Team Development

  • Lead, manage, and develop a high-performing team of 810 direct reports, including local study project managers and clinical study administrators
  • Drive performance management, training, coaching, and career development aligned with business needs and individual development goals
  • Manage workload allocation, resource optimization, and team succession planning in partnership with senior leadership and HR
  • Provide input on compensation, bonus proposals, and promotions in collaboration with HR and the US Head of County Operations

End-to-End Study Oversight

  • Oversee the execution of Phase 2 & 3 interventional studies across site feasibility, start-up, recruitment, maintenance, and close-out
  • Ensure trial milestones and deliverables are achieved with high quality and within agreed timelines
  • Robust oversight of site performance, study documentation, eTMF completeness, and regulatory compliance

    • Project Management & Operational Delivery

  • Monitor key performance indicators (KPIs) and operational metrics across assigned TA to ensure quality and consistency
  • Identify and mitigate operational risks, issues, and roadblocks in collaboration with global study teams and local partners
  • Drive process improvements, standardization, and adoption of country-level best practices
  • Lead transformation and change initiatives to strengthen the local Clinical Operations Management (COM) function

    • Stakeholder & Vendor Engagement

  • Collaborate cross-functionally with local Medical Affairs, Regulatory, Legal, Development Quality, and other internal partners
  • Manage external vendor performance, including CROs and FSPs, ensuring alignment with clinical objectives and standards
  • Maintain effective communication pathways with global study teams, Start-Up Managers, Site Partnership functions, and CRA managers
  • Represent the local TA perspective in broader country strategy discussions

    • Qualifications

  • Bachelor's degree in life sciences or related field (Master's or PhD preferred)
  • Minimum 7 years of experience in clinical research, including significant exposure to Phase 2 / 3 interventional trials
  • At least 3 years of direct people management experience in clinical operations
  • Demonstrated success managing cross-functional and vendor relationships
  • Strong working knowledge of ICH-GCP, global regulatory requirements, and local trial execution environments
  • Proven ability to drive delivery across multiple concurrent studies in a fast-paced, matrixed environment
  • Excellent communication, influencing, and stakeholder management skills

    • Preferred Qualifications

  • Previous experience as a field CRA
  • Experience in rare or ultra-rare disease trials, including pediatric or complex patient populations
  • Experience with U.S.-based studies and site management
  • Solid background in inspection readiness, risk mitigation, and continuous improvement
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