Clinical Data Compliance Specialist

vor 3 Wochen


Berlin, Berlin, Deutschland Thermo Fisher Scientific Vollzeit

Key Responsibilities

  • Coordinate operational compliance activities on one or more studies to ensure successful delivery of the studies.
  • Ensure accurate and timely entry of all data in the CRF from the source notes, and tracks the flow of the CRF's, queries, and patient recruitment statuses; reports out the flow of data.
  • Maintain ISF and study trackers as delegated.
  • Follow the QC process and checks that ICF's are correctly completed.
  • Ensure that protocol visit windows are scheduled according to the protocol requirements and reports deviations.
  • QC's all supporting reports (laboratory reports/GP SDV/Consultant) to ensure they are reviewed and signed off by a physician within the appropriate timelines and flags any out of range values.
  • Assist with archiving procedures if required.
  • Assists monitors, sponsor representatives with the preparation of monitoring visits and query resolutions during monitoring visits.
  • Identify quality issues (QI) and to reports them, and applies CAPA reporting and root cause analyses.
  • Prepare and collate regulatory documents for submission.
  • Interpret and adhere to company SOP and COP, and assists with input during the review process.
  • Adhere to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations.
  • Assist with drafting compliance reports.


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