We are currently working on a large global project for one of our CRO partners where they are looking to several Senior / Lead Clinical Data Managers to work on an FSP model, directly outsourced to an international Pharma.
This position will be focused on leading studies across cross-functional study teams within the sponsor and is limited to remote workers in the UK.
Responsibilities:
- Act as the primary data lead within cross-functional study teams
- Lead study start-up activities by coordinating EDC build & configuration, system integrations, user acceptance testing (UAT), and the timely completion of key data management milestones.
- Manage ongoing data review processes, reconciliation activities, vendor oversight, and database lock readiness to maintain data quality and study timelines.
- Maintained adherence to CDISC standards, ICH-GCP guidelines, and applicable regulatory requirements throughout the clinical trial lifecycle.
- Proactively assess and address project risks while implementing process improvements to enhance operational efficiency and overall data management quality.
Experience Required:
- Life Science degree
- Proven track record working in data management within clinical trials
- Previous experience independently leading studies
- Knowledge of CDISC standards
- Strong understanding of the clinical trial process, regulatory requirements, and ICH-GCP
- Strong hands-on experience with EDC systems (Veeva preferred)
For more information, please submit your application or reach out to:
Jack Kavanagh
AL Solutions
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