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About the role
- Director, Clinical Operations leading clinical trials for women's health devices. Overseeing study execution and collaborating with cross-functional teams for product commercialization.
Responsibilities
- Lead the clinical development of women’s health devices and diagnostics from early feasibility stages through regulatory submission and commercialization.
- Drive cross-functional R&D initiatives, aligning clinical objectives, timelines, and budgets with overall program strategy.
- Oversee all aspects of study execution, including protocol development and site selection.
- Collaborate with biostatistics, data management, legal, and regulatory teams to ensure robust study design.
- Manage external partners, including CROs, ensuring performance, issue resolution, and audit readiness.
- Prepare for and support regulatory inspections and global submissions.
Requirements
- Bachelor’s degree or equivalent and a minimum of ten years of clinical trial management.
- Proven track record of leading large global clinical trials in medical devices, diagnostics, pharmaceuticals, or drug-device combination products.
- Demonstrated experience managing complex specimen logistics and imaging workflows in global, multi-center studies.
- Experience in women’s health is preferred.
- Thorough knowledge of ICH-GCP and regulations and requirements for clinical trial authorization.
- Strong interpersonal skills and outstanding written and verbal communication skills.
- Excellent understanding and proficiency with Microsoft Office, including strong MS Project skills.
- Ability and willingness to travel up to 30% including international travel as required.
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Hybrid work arrangements
- Professional development opportunities
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