Company: CK Clinical
Closing Date: 28 Dec 16
Salary (£): Competitive
Stephanie Maccioni is currently recruiting for a Clinical Data Standards Project Manager to join a leading pharmaceutical company on site in Belgium. This is a...
Stephanie Maccioni is currently recruiting for a Clinical Data Standards Project Manager to join a leading pharmaceutical company on site in Belgium. This is a 6 month contract.
Main duties and responsibilities:
-Accountable for supporting the submission SDTM experts in their contributions to IDAR submission strategy, planning and implementation activities to make sure IDAR adheres to Regulatory Authority and Industry standards for submissions
-This position highly contributes in making sure the IDAR department adheres to Regulatory guidances and acceptable standards for Authorities related to submission data standards and should keep up to date with all evolutions in these guidances.
-Provide guidance to IDAR staff related to data submission activities and ensures training to IDAR staff, other departments eg EBIS and CRO's is provided.
-You will also be very much involved in supporting business (data delivery) in P21E validations.
-BA/BS degree or professional experience equivalent is required.
-This position requires an in-depth knowledge of SDTM standards and a good knowledge of SDTM standards, submission processes and requirements.
-A thorough understanding of clinical research processes and regulations is required.
Full job spec available upon request
CK Clinical is an Equal Opportunities employer who 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 CL37714 in all correspondence.
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