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Jobs or company...

Associate Director/Director, Data Management

Salary undisclosed

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Overview

Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Associate Director/Director, Data Management will help advance this mission by developing and executing data management plans across therapeutic areas and in all phases of clinical development. S/he will report to the VP, Biostatistics.

Responsibilities
  • Serve as the lead clinical data manager for assigned clinical trials, providing input to protocols, designing and reviewing case report forms, providing input to database development, and performing all data management-related activities
  • Provide oversight of data management CROs, ensuring data management documents and tasks are completed and delivered in accordance with timelines and data quality standards
  • Provide expertise and guidance to the Clinical Development and Clinical Operations teams regarding data standards
  • Oversee database status with respect to key performance indicators, metrics, and program-level deliverables and timelines
  • Contribute to project resource planning and program deliverable timeline
  • Understand inspection readiness/regulatory considerations for the role and help prepare responses to inquiries from FDA and other health authorities on data management-related topics
  • Serve as primary development team point of contact for all data management-related issues; contribute to the development of relevant policies and procedures
  • Maintain up-to-date knowledge of data management requirements

Qualifications

  • Bachelor's degree in one of the life sciences, or equivalent knowledge and experience
  • 10+ years of experience in biopharmaceutical industry or related field, with 7+ years in data management
  • Ability to create data management study documents (CRF guidelines, trial design documents, edit check specifications, data review plan, etc.)
  • Proficiency with multiple data management processing systems
  • Organized and thorough with attention to details
  • Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive for results
  • Demonstrated communication, problem-solving, and decision-making skills
  • Natural collaborator who enjoys working on a cross-functional team
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