Lead and oversee global clinical trial operations, managing cross-functional teams, CROs, and vendors. Shape clinical strategy from protocol design to study execution, ensuring trials are on time and within budget. Drive patient recruitment strategies and engage with Key Opinion Leaders. Optimize vendor partnerships, track KPIs, and manage study timelines, budgets, and risk mitigation plans. Collaborate cross-functionally with Regulatory, Medical Affairs, Supply Operations, and more. Bachelor's Degree is required. An advanced degree in a scientific and/or business/finance discipline is preferred 5+ years of clinical research experience, including global late-stage (Phase 2-4) trials. 2-4+ years in clinical project management, ideally with rare diseases or hard-to-recruit populations. Experience with protocol, ICF, CRF, CSR development and review Strong regulatory knowledge (GCPs), vendor management expertise, and experience leading multinational studies. Experience in novel clinical drug development Exceptional organizational, problem-solving, and leadership skills. Phase 3 oversight experience Exposure to leadership meetings and strategy development EU CTR experience Rare disease or hard to recruit population experience Ability to apply project management best practices to programs
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