Clinical Data Project Manager required for worldwide pharmaceutical company based in Belgium.
A Worldwide Pharmaceutical company with offices in Belgium are looking for an experienced Clinical Data Project Manager to join their team. If you are an experienced Data Manager that is looking to explore new cultures, whilst working in a challenging and stimulating environment this might just be the role for you.
In this role you will manage outsourced studies in EDC from set-up to Data base lock, providing Data Management support for Clinical Databases with limited supervision.
Further key responsibilities of this Clinical Data Project Manager job will include:
- To manage projects according to strict timelines.
- To manage ‘end to end’ process of outsourced studies.
- To maintain internal database standards for data reporting in collaboration with CDISC.
- To specify the study structure and validation according to protocol specifications.
- To design and study specific eCRFs
- To produce, co-ordinate and perform user acceptance testing
- To perform data validation
- To perform SAE reconciliation where necessary
- To manage and monitor change requests to eCRF and external databases
- To develop and maintain working practices
- To participate in Computer Systems Validation of in-house technologies
- To maintain study documentation
- To be the main liaison for all CRO/EDC vendors Essential Key Requirements
- Several years experience in Clinical Data Management within the pharmaceutical industry
- Sound knowledge of the drug development process, Data Management process and medical terminology
- Clean, quality data for statistical reporting Main Demands
- Ensuring work is compliant with ICH GCP and regulatory requirements
- Ensuring compliance with 21 CFR Part 11 Electronic Records; Electronic signatures
If yourself or anyone you know might be interested in working in this interesting and challenging position please contact Sarah Brunnen on 01438 743047, or email firstname.lastname@example.org.
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