Director, Country Operations Management
- Lead, manage, and develop a high-performing team of 8–10 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.
- 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.
- 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.
- 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
- 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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