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Senior Clinical Data Manager II

1 month 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. The successful candidate will be responsible for providing oversight for 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 lead the planning and execution of data management activities on assigned studies.
  • Ensure all Data Management study documents are developed and archived.
  • Establish and lead the Data Working Group (DWG) for assigned studies.
  • Develop and maintain Data Management timelines.
  • Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting.
  • Effectively identify and mitigate risks to Data Management deliverables.
  • Provide a high level of expertise in data management to support clinical studies.
Requirements
  • Bachelor's degree in a related discipline and a minimum of 9 years of related experience, or Master's 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.
  • 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.
What We Offer

Exelixis offers a 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. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.