Data Compliance Coordinator - Manchester, United Kingdom - Thermo Fisher Scientific
Description
Our team of colleagues in clinical research services are at the forefront of getting cures to market.We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns.
Our Clinical Research team, who powers our PPD clinical research portfolio, are part of our leading global contract research organization (CRO).
PPD, now Thermo Fisher's clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.
- to improve health
Accelerated Enrollment Solutions (AES) is a business unit of PPD that helps biopharmaceutical companies overcome patient recruitment and research site challenges by optimizing each step in the patient journey to deliver greater speed, certainty, and control to clinical trial delivery.
We are currently looking to recruit a Data Compliance Coordinator for our clinical site in Manchester.
Working 37 hours a week, Monday to Friday, this role will be responsible for oversight of data and quality control to the clinical trial process by ensuring all study documentation and source data is accurate and up to date.
- 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.
- 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
Our 4i Values:
Integrity - Innovation - Intensity - Involvement
LI-TK2 #AES
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