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.
Responsibilities:
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.
Qualifications:
Bachelor or Master’s degree in science, health studies and research fields Minimum of 14+ years of clinical research experience
