Senior Clinical Data Manager II

hace 3 semanas

Caimito Barrio, Puerto Rico Exelixis A tiempo completo
Job Summary

We are seeking a highly skilled Clinical Data Manager II to join our team at Exelixis. In this role, you 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, and establish and lead the Data Working Group (DWG) for assigned studies.
  • Develop and maintain Data Management timelines, track and manage progress towards data deliverables, and effectively identify and mitigate risks to Data Management deliverables.
  • Provide a high level of expertise in data management to support clinical studies, and provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status.
  • Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding, and support the transfer, locking, and archiving of study databases.
  • Prepare recommendations for new or improved processes for data management and data flow, and work collaboratively with cross-functional stakeholders to ensure project deliverables and timelines are met.
  • Direct and oversee activities of Data Management staff assigned to studies and tasks within projects, and perform project level resource management in conjunction with CDM Management.
  • Lead electronic submission activities for Data Management as appropriate, and participate in selecting outsourcing partners for assigned studies, including input to Request for Proposal (RFP) review, proposal evaluation, and capabilities presentations.
  • Provide oversight of vendors providing Data Management services, and develop and execute study specific training of staff within a project.
  • Lead or participate in CDM process improvement initiatives, and promote and be an advocate for CDM internally and externally.

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, or an equivalent combination of education and experience.
  • A minimum of 7 years of clinical data management experience in the pharmaceutical industry or clinical trials, and 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:

  • A competitive salary range of $143,000 - $203,000 annually, based on the candidate's geographic region, job-related knowledge, skills, experience, and internal equity.
  • 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.
  • A discretionary annual bonus program, or a sales-based incentive plan for field sales staff.
  • The 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.

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