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Clinical Operations Director
hace 1 mes
Jobleads-Us is seeking a highly experienced Clinical Operations Director to join our team in the greater Boston area. As a key member of our neurology-focused clinical trials team, you will play a critical role in shaping the future of neurological disease treatment.
About the RoleWe are partnered with a leading biotech company that has generated over half a billion dollars in funding since 2021. Their novel precision medicine approach is revolutionizing the way we combat neurological diseases. In this newly created role, you will be integral in their phase 3 trial and will also have oversight of their early phase pipeline.
Responsibilities- Lead and oversee all clinical operations activities, ensuring alignment with company goals and objectives in neurology-focused clinical trials.
- Plan, initiate, execute, and close clinical trials, managing timelines, budgets, and quality standards, and ensuring compliance with GCP and regulatory guidelines.
- Work closely with Clinical Development, Regulatory Affairs, Medical Affairs, and Data Management teams to align on trial objectives and ensure successful execution.
- Oversee relationships with CROs and vendors, ensuring adherence to contracts and high-quality deliverables.
- Ensure all trials meet regulatory requirements, including ICH-GCP guidelines, and support the preparation of regulatory submissions.
- Supervise the collection, analysis, and reporting of clinical trial data, maintaining accuracy and integrity.
- Build, lead, and mentor a high-performing clinical operations team, fostering a culture of collaboration and excellence.
- Develop and manage clinical operations budgets, monitoring financial performance and making adjustments as needed.
- Identify and implement best practices to enhance clinical operations efficiency and effectiveness.
- 7+ years of experience in clinical operations, with 3 years of experience in a leadership role.
- Experience with CNS disorders and relevant therapeutic areas.
- Experience managing CROs and excellent communication with vendors and other external partners.
- A strong work-life balance with flex work from home days and access to wellness programs.
- A home office stipend.
- Gym and work-out studio subsidies.
- Catered meals and snacks on in-office days.
- 4 weeks PTO.
