Job Summary
A staffing company is filling a position for a Remote Senior Clinical Data Manager in Boston.
Core Responsibilities Include:
- Working on the development of data management documentation including CRFs, CCGs, edit check specifications, SAE reconciliation plans, Coding plans, Data Management Plans, and third-party vendor data specifications
- Coordinating related reviews with cross functional team(s)
- Running and participating in UAT of clinical data management systems, clinical data review and data reconciliation
Skills and Requirements Include:
- 5+ years of clinical data management experience at Sponsor, CRO, and/or Investigative site
- Proficiency in Microsoft applications including Word, MS Project, Powerpoint
- Proficiency in clinical EDC systems (Medidata Rave), J-Review, BOXI, and/or other CDM reporting tools
- Knowledge of, and experience with CDISC/CDASH standards
- Background working with central and specialty labs/vendors
- Understanding of medical terminology and medical coding dictionaries including MedDRA and WHO Drug
