San Mateo, CA, 94497, USA
1 day ago
Director, Global Medical Affairs, Sponsored Phase IV Studies
**General Description:** + Work with country or global teams to plan and implement Phase IV GMA-sponsored clinical trials, interventional or non-interventional + This includes all aspects of study management and oversight, including working with the CRO, engaging with non-GMA stakeholders for alignment, project management, data management, safety planning, etc. **Essential Functions of the job:** + Create the global governance structure and implementation process for these studies. + Build capabilities and infrastructure for GMA-sponsored studies; interventional and non-interventional. + Build the templates, tracking and reporting process for these studies for leadership and non GMA members. + Create a global Sharepoint site to house all required documents and oversee all data is added to the appropriate systems (GMA portal, ClinOps portal). + Work with the responsible party (eg Country Medical Director, HEOR lead) to create the implementation and operations plan for a GMA-sponsored study. + Create the governance structure and planning forum for each study. + Manage and track study-specific activities and deliverables. **Education Required:** + Master's or Doctorael level degree required. **Qualifications:** + Master's or Doctorate level degree with 10 + years of experience in the pharmaceutical industry. + 5 + years of experience in managing company-sponsored clinical trials within the pharmaceutical industry. + Preferred: Experience conducting post-marketing company-sponsored trials (interventional & non-interventional). + Experience managing a CRO, understanding of global regulatory requirements for company-sponsored trials. + Detail-oriented, organized, excellent written & verbal communication skills. + Able to function in a fast-paced environment, self-directed. **Supervisory Responsibilities:** + Yes **Computer Skills:** + Excel, PowerPoint, Project Management Software, Smartsheet, data management databases (eg CTMS), Veeva or similar. **Travel:** + <10% All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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