Data Compliance Coordinator

at  Thermo Fisher Scientific

TO BE CONSIDERED FOR THIS EXCITING OPPORTUNITY YOU WILL REQUIRE THE FOLLOWING SKILLS AND EXPERIENCE:

• 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
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• Coordinates operational compliance activities on one or more studies to ensure successful delivery of the studies.
• Ensures 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.
• Maintains ISF and study trackers as delegated.
• Follows the QC process and checks that ICF’s are correctly completed.
• Ensures that protocol visit windows are scheduled according to the protocol requirements and reports deviations.
• QCs 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.
• Identifies quality issues (QI) and to reports them, and applies CAPA reporting and root cause analyses.
• Prepares and collates regulatory documents for submission.
• Interprets and adheres to company SOP and COP, and assists with input during the review process.
• Adheres to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations.
• Assists with drafting compliance reports