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Job Description
Clinical Trial Program Lead
Lead a team in the development of clinical asset strategies for phase 1, leveraging quality decision-making principles, and provide technical leadership and operational oversight of clinical research trials.
**Responsibilities:** • Develop and implement clinical project management processes and tools • Collaborate with cross-functional partners to manage clinical budgets and identify and mitigate clinical risks • Partner with regulatory and medical teams to ensure safety management and monitoring processes are implemented • Develop and maintain up-to-date clinical plan timelines and process maps • Oversee clinical trial operations and delivery of clinical project milestones on time and on budget • Manage vendors and provide oversight for operational deliverables • Collaborate with the global clinical team to resolve clinical implementation issues **Requirements:** • Bachelor's degree in a science-related field • 3 years' experience in the pharmaceutical industry with direct experience of managing clinical studies (5+ years preferred) • Strong knowledge of ICH GCP • Early Phase (Phase 1) experience preferred • Advanced scientific degree • Strong leadership and networking skills • Vendor management and contracting experience • Demonstrated high-level computer skills (e.g., word processing, spreadsheets, presentations) • Ability to influence and oversee Third Party Organizations (TPOs) to enable delivery of trial level deliverables • Demonstrated knowledge and experience with project management tools and processes • Excellent oral and written communication skills