Senior Clinical Data Manager II

4 weeks ago

Alameda, California, United States EXELIXIS Full time
Job Summary

We are seeking a highly skilled Clinical Data Manager II to join our team at Exelixis. As a key member of our data management team, you will be responsible for overseeing the execution of data management activities at the program level, from study start-up through to regulatory submission.

Key Responsibilities
  • Collaborate with cross-functional teams, external partners, and support data managers to ensure project deliverables are met with quality and on time.
  • Lead the planning and execution of data management activities on assigned studies, ensuring all data management study documents are developed and archived.
  • Establish and lead the Data Working Group (DWG) for assigned studies, developing and maintaining data management timelines.
  • Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting.
  • Identify and mitigate risks to data management deliverables, resolving data handling-related issues and providing expertise in data management to support clinical studies.
Requirements
  • BS/BA degree in a related discipline and a minimum of 9 years of related experience, or MS/MA degree in a related discipline and a minimum of 7 years of related experience, or PhD in a related discipline and a minimum of 2 years of related experience.
  • Minimum of 7 years of clinical data management experience in the pharmaceutical industry or clinical trials, with a minimum of 4 years in a project leadership role.
  • Experience with Electronic Data Capture (EDC) is required, and experience with Interactive Voice or Web Response Systems (IVRS/IWRS) is preferred.
  • Demonstrated experience leading data management teams is preferred.
What We Offer
  • Comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
  • Discretionary annual bonus program, or sales-based incentive plan for field sales staff.
  • Opportunity to purchase company stock and receive long-term incentives.
  • 15 accrued vacation days in the first year, 17 paid holidays, including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
About Exelixis

Exelixis is a biopharmaceutical company dedicated to the discovery and development of innovative therapies for the treatment of cancer. We are committed to making a difference in the lives of patients and their families, and we are seeking talented individuals to join our team.

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