Location: Home based - Spain or Poland
Geoff King at RBW Consulting is working with an international, full service CRO in the recruitment of a Senior Data Manager to work as part of the global multi sponsor team.
Established over 20 years ago this and now operating across the globe, this full service CRO provide premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.
As Senior Data Manager you will have the opportunity to join a well established team of over Data Managers based across Europe working on phase 1-4 clinical trials in multiple therapeutic areas including Oncology, Hematology, CNS, Rare Disease and more.
The Senior Clinical Data Manager reports to the Data Management Coordinator, serves as primary point of contact to the study team for clinical data related matters and ensure clinical data is managed in compliance with applicable standards, regulatory guidelines and company SOPs.
Main duties & responsibilities:
Ensure data is managed in compliance with applicable standards (e.g. CDISC), regulatory guidelines and SOPs;
Prepare Data Management documents (CRF, Data Management Plan, Data transfer specifications, etc.)
Design the paper and/or electronic Case Report Forms (CRF), including paper PROs (diaries, questionnaires), in co-operation with the Sponsor, and the study team;
Prepare and validate the eCRF/clinical databases and related tools;
Manage database locks and freezing before data analysis;
Prepare, maintain, and archive data management documentation;
Liaise with Sponsor and external stakeholders regarding data management activities;
Min. 3 years’ experience within Data Management
Digital skills and good knowledge of FDA 21 CFR Part 11 and system validation;
Solid knowledge on relational databases and programming languages;
Knowledge of CDISC standard specifications;
English language (fluent reading, writing and verbal skills);
A comprehensive job description is available upon request.
To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on +44 (0) 1293 584 300 and send your CV through to firstname.lastname@example.org or use the apply button on this page.
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.
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