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Senior Clinical Data Manager

New Jersey All, NJ

Posted: 10/09/2018 Job Type: Clinical Job Number: JN -102018-22772
  • Participate in CRO selection
  • Review SOWs/data management activities and costs in contracts
  • Interact with CROs in the design and development of CRF's, databases that are compatible with Standards, CDISC and all other company needs
  • Perform QC of CRO activities to include UAT, Query management, Data review, DM documentation such as DMP, DVS, edit checks, coding, lock process
  • Monitor progress of data management activities by CROs
  • Participate in regular team meetings and provide input when appropriate
  • Ensure inspection readiness by ensuring quality eTMF
  • Proficient in writing function SOPs/Working Practices
  • Interact with CRAs, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
  • Assist in database upgrades/migrations including performing QC of CRO User Acceptance Tests
Skills/Knowledge Required:
  • BS/BA degree or equivalent in a relevant scientific discipline
    Minimum of five years of experience as a Lead Data Manager in a pharmaceutical/CRO setting
  • Experience in Hematology and or Oncology
  • Proficient knowledge of EDC databases, preferably Medidata RAVE
  • Basic knowledge of budget forecasting
  • Excellent communication skills
  • Ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
  • Proficiency in regulatory guidelines, agencies and GCP
  • Advanced knowledge of clinical trial process and data management process
  • Must have experience in managing data management deliverables end to end

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