Data Compliance Specialist

vor 1 Monat

Berlin, Berlin, Deutschland Thermo Fisher Scientific Vollzeit
Job Title: Data Compliance Coordinator

About the Role:

We are seeking a highly motivated and detail-oriented Data Compliance Coordinator to join our team at Thermo Fisher Scientific. As a Data Compliance Coordinator, you will play a critical role in ensuring the accuracy and integrity of clinical trial data.

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 track the flow of the CRF's, queries, and patient recruitment statuses; report out the flow of data.
  • Maintain ISF and study trackers as delegated.
  • Follow the QC process and check that ICF's are correctly completed.
  • Ensure that protocol visit windows are scheduled according to the protocol requirements and report deviations.
  • QC all supporting reports (laboratory reports/GP SDV/Consultant) to ensure they are reviewed and signed off by a physician within the appropriate timelines and flag any out of range values.
  • Assist with archiving procedures if required.
  • Assist monitors, sponsor representatives with the preparation of monitoring visits and query resolutions during monitoring visits.
  • Identify quality issues (QI) and report them, and apply CAPA reporting and root cause analyses.
  • Prepare and collate regulatory documents for submission.
  • Interpret and adhere to company SOP and COP, and assist 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.

Requirements:

  • Fluent in German and English
  • Good time management and multitasking skills in order to coordinate several studies with a number of participants simultaneously
  • Appropriate MS Office Skills
  • Good attention to detail

About Us:

Thermo Fisher Scientific is a leading provider of scientific instrumentation, software, and services. We are committed to enabling our customers to make the world healthier, cleaner and safer. Our team of over 100,000 colleagues shares a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

Equal Employment Opportunity:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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