Principal Clinical Data Manager
Laura Christie at CK Clinical is recruiting for a Principal Clinical Data Manager for a CRO based in Belgium on a permanent basis.
Main duties and responsibilities
- Responsible for the project management and complete oversight of clinical trial data, and ensure documentation according to agreed timelines and quality expectations.
- Be the liaison between the trial customer, the CRO's and other functional partners for all aspects related to data for assigned trials
- Ensure inspection readiness of all data management deliverables and adequate archiving of data management documentation
- Liaise continually between the CRO, the trial customer and other internal and external partners to establish, align and confirm data management expectations for assigned studies
- Gather content and integration requirements for eCRF and other data collection tools
- Establish conventions and quality expectations for clinical data
- Establish expectations for dataset content and structure
- Set timelines and follow-up to ensure delivery of all Data Management milestones
- You plan and track content, format, quality, and timing of data management deliverables, including, but not limited to: CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival; ensures deliverables are on time and within budget
- BSC or MSc within Life Sciences
- Must have relevant industry exp with proven track record within Data Management
- Have working knowledge of CDISC and SAS
- Understanding of current clinical drug development processes
- Knowledge of applicable international guidelines regarding Data Management of clinical trials.
For more information or to apply for this role, please contact Laura Christie with your CV on 07443 111928 or email LChristie@ckclinical.co.uk. Alternatively, please click on the link to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL34220 in all correspondence.