Manager, Data Quality & Standards, Hertfordshire

C.K. Associates Limited
08 Mar 2018
16 Mar 2018
Contract Type
Full Time
Jim Gleeson is recruiting for a Manager, Data Quality & Standards to oversee clinical disclosure activities (primarily and EudraCT) for a successful global pharmaceutical company in Hertfordshire.

Key duties will include:
- Oversight and management of disclosure and transparency activities, ensuring procedures are maintained in line with evolving regulations
- Line management of the disclosure team
- Analysis of procedures for gaps and driving improvements to enhance efficiency and timeliness of activities
- Coordination across departments to ensure consistency of the overall study disclosure activities
- Development and maintenance of records to document compliance status

As Manager, Data Quality & Standards you will require the following:
- A relevant science degree
- Strong pharmaceutical industry experience gained in clinical disclosure, regulatory affairs or clinical operations
- A good knowledge of clinical transparency rules such as FDAAA801, EudraCT, EMA Policy 70, PhRMA / EFPIA principals for data sharing etc
- Experience with study registration and disclosure on
- The ability to proactively gather, interpret, summarize and simplify transparency intelligence

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group 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 CL41452 in all correspondence.
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