Clinical Data Manager
Laura Christie at CK Clinical is recruiting for a Data Manager for an international Pharmaceutical company based in Switzerland on a contract basis.
Main duties and responsibilities:
- Ensure Clinical Development Data Management (CDDM) activities related to assigned study adhere to standard and applicable regulations.
- Meet timelines and applicable regulations.
- Ensure data handling consistency within allocated activities.
- Participate in the development of the eCRF in line with standards.
- Contribute to writing all study Data Management documents (e.g. specifications for external data transfer, data cleaning and review tools).
- Test the data entry screens (eCRF layout), data cleaning/review tools and their implementation in the production environment.
- Perform Data Review (discrepancy and query management, database updates). Protocol Deviations Management and contributes to database lock activities.
- Provide the TDS/project DS with activity metrics upon request.
- Prepare and archive CDDM study documentation.
- Perform QC: Periodic operational checks to verify that clinical data are handled according to the protocol, applicable quality system documental and GSP.
- Participate in the development and review of policies, standard operating procedures and associated documents for CDDM.
- BSC or MSc within Life Sciences
- Must have relevant industry exp with proven track record within Data Management
- Understanding of clinical trial databases and applications, clinical data flow, data review, and eCRF design
- Ability to work in an international environment
- Good knowledge of international clinical research regulations and requirements (e.g., International Conference on Harmonization - Good Clinical Practice (ICH-GCP)).
- Fluent in written and spoken English.
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 CL34467 in all correspondence.