Head of Clinical Operations
- Provide high level and complex scientific and clinical guidance to OTC switch studies
- Oversee CROs’ study management, Biometrics, Global Drug Safety, Regulatory and Project Management to meet project deliverables and timelines
- Primary oversight of CRO conduct for ongoing clinical trials
- Provide ongoing clinical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice and SOPs
- Develop and implement operational plans and direct resources for new clinical studies from initiation through archival of TMF
- Oversight of CRO contracting process (Master Service Agreements, Work Orders, Change Orders)
- Oversight of Monitors (appropriately qualified external third party or internal CRA)
- Coordinate the collection and assimilation of ongoing data for internal analysis and review.
- Coordinate and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
- Drafting and reviewing parts of FDA submission documents.
- Presents scientific information at clinical study investigator meetings
- Develop and manage departmental budgets to effectively achieve corporate goals
Required Skills and Experience
- Rx to OTC switch study research & operations expertise and experience, including experience on an actual use trial (AUT)
- A minimum of 10 years’ experience in pharmaceutical or consumer healthcare, with a minimum of 5 years in clinical operations.
- Excellent scientific written communication skills, including experience drafting parts of FDA submission documents
- Strong familiarity with regulatory strategy and good clinical practices and International Conference on Harmonization Guidelines is preferred
- Ability to work highly effectively with multi-disciplinary team
- Capable of working with attention to detail in a time sensitive environment
- Excellent organizational skills