Senior Director
Data Management
Posted on 3/20/2023
Belmont, MA, USA
Experience Level
  • Minimum of 10 years of experience in data management, with 5 years in oncology preferred
  • 3 years of people management experience, including the training and development of personnel
  • Master's degree in life sciences, pharmacy or related discipline preferred
  • Expert proficiency, complete knowledge and understanding of DM and processes, procedures, and roles
  • Demonstrated proficiency managing the lifecycle of clinical data projects
  • Extensive experience in BLA, NDA/s NDA regulatory submissions
  • Experience in developing and implementing SOPs
  • Possess a thorough knowledge of medical terminology and the clinical trial process including extensive knowledge of biostatistics, data management, pharmacovigilance and clinical operations functions
  • Proficient in developing requests for proposals for external vendor contracts and in evaluating external vendor capabilities
  • Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the company
  • Demonstrate effective time management and organizational skills including the ability to work under deadlines and on multiple projects simultaneously
  • Willingness to roll up his/her sleeves and get things done
  • Manage and oversee vendors, contractors and internal personnel on data management activities for all clinical studies. Accountable for external vendor timeline management
  • Build and retain a world class internal data management team
  • Provide project management and technical guidance/expertise to ensure operational and technical excellence
  • Manage aspects of data management activities, including oversight on vendor performance, internal metrics, quality assurance checks and communication of trial status within and outside the trial team
  • Develop, implement, and version DM processes and standards
  • Review, and comment on CRFs, annotated CRFs, and edit checks and related documents
  • Collaborate with biostatistics, programming, and clinical to provide DM support
  • Could serve as a lead data manager for a pivotal project if needed
Kymera Therapeutics

51-200 employees