Vice President / Glocal Head of Clinical Operations
Healthcare
Job Description
The Director of Clinical Operations is responsible for partnering with Clinical Operations teams to deliver high-quality, client-focused, and operationally efficient clinical study startup services. This role provides strategic oversight during the startup phase of clinical trials and serves as a subject matter expert for study startup activities, building strong relationships with sponsors and cross-functional stakeholders. The Director also contributes to operational excellence through involvement in team development, resource planning, process improvement, and overall study startup performance.
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Responsibilities:
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- Lead and oversee clinical study startup teams and startup activities to ensure timely, compliant, and high-quality execution aligned with study protocols, SOPs, regulatory requirements, and sponsor expectations.
- Collaborate with Clinical Operations leadership, Project Managers, sponsors, and cross-functional teams to develop and implement effective startup strategies that support study timelines and enrollment goals.
- Drive study startup performance across key activities including site identification, feasibility assessments, site selection, ethics and regulatory submissions, site activation, contract and budget negotiations, and essential document collection.
- Ensure the accuracy, quality, and completeness of startup deliverables through review of regulatory submissions, essential documents, startup trackers, and study records.
- Lead and support feasibility assessment activities and site selection strategies by evaluating site capabilities, patient populations, competing studies, and operational risks.
- Support hiring, onboarding, training, resource allocation, and performance management initiatives to strengthen operational effectiveness and team development.
- Contribute to process improvement initiatives, audit readiness, and operational best practices to support overall organizational goals and quality standards.
- Foster strong client relationships and long-term partnerships through proactive communication, strategic collaboration, and consistent delivery of high-quality startup services.
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Qualifications:
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- Bachelor or Master’s degree in science, health studies and research fields
- Minimum of 14+ years of clinical research experience
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