Clinical Data Manager (6-month Contract)

Zymeworks

Bellevue, WA, United States
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Clinical data management documentation
Data cleaning process
Vendor/cro oversight experience
** Zymeworks is seeking a Clinical Data Manager for a 6-month contract in Bellevue, WA, requiring a hybrid work schedule with at least three days onsite. The ideal candidate will have extensive experience in clinical data management and a thorough understanding of regulatory guidelines. **

Job Summary

  • Oversees/participates in clinical data management project activities performed by vendors/CROs to ensure activities are performed with the highest quality.
  • Contributes to the development/review of relevant data management documentation, including but not limited to CRFs, CRF Completion Guidelines, Data Management Plans, Edit Check Specifications, etc.
  • We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth.

Matching Summary

Match Score: 75

** Zymeworks is seeking a Clinical Data Manager for a 6-month contract in Bellevue, WA, requiring a hybrid work schedule with at least three days onsite. The ideal candidate will have extensive experience in clinical data management and a thorough understanding of regulatory guidelines. **

Skills & Requirements

Must-have

  • clinical data management documentation
  • data cleaning process
  • vendor/CRO oversight experience
  • Medidata Rave experience preferred

Nice-to-have

  • oncology experience
  • ePRO, SharePoint, J-Review experience
  • database development experience
  • programming experience
  • interpersonal and collaborative skills

Key Requirements

  • BA or BS and 8 years related experience
  • Thorough knowledge of FDA regulations, ICH GCP guidelines
  • Knowledge of SDTM, CDISC
  • Experience with EDC, IXRS, RTSM

Work Rights

Not specified

Tailored Resume

Cover Letter