Data Quality & Standards Manager
Data Quality and Standards Manager - Hertfordshire
A world renowned Pharmaceutical and Research organisation based in Hertfordshire have opened a unique position for a Data Quality and Standards Manager to join their Regulatory department to assist in setting up an exciting new clinical trials transparency division! This is a chance to be part of the development of an entirely new field, and gain invaluable experience, as well as potentially rapid career progression!
As a Data Quality and Standards Manager, your duties/responsibilities will involve:
Overseeing clinical disclosure activities (clinicaltrials.gov and EudraCT), as well as generally supporting other departments with related issues
Spreading awareness of current transparency regulations and ensuring that all procedures are maintained accordingly
Supervising and supporting and mentoring junior members of the disclosure team, and reporting an compliancy issues to the Associate Director of DQ & S.
Support the DQ & S in activities related to Master Data Management development projects and regulatory reporting
The ideal candidate will possess:
Educated to degree level
Experience of the pharmaceutical industry, ideally with a strong knowledge of regulatory affairs or clinical operations
Strong knowledge of clinical transparency obligations which can include EudraCT, EMA Policy 70, EFPIA/PhRMA, FDAAA801
Experience of study registration and disclosure on clinicaltrials.gov
Excellent communication in both written and spoken English
Computer skills, especially excel and databases
This is a very exciting position for a driven, ambitious individual looking for their next step in a thriving, global pharmaceutical organisation. The successful candidate will be second in command of a rapidly expanding industry, so if you meet the above criteria and are looking for fast career progression and managerial responsibility, this is the role for you. To hear further details, please call myself, Emilie Francis, on 0121 616 3477, or send a copy of your recent CV to firstname.lastname@example.org
Clinical disclosure, Study Registration, Clinical Operations, Regulatory Affairs, Transparency, Data, Data Quality, Hertfordshire, St Albans, Stevenage, Hemel Hempstead, Hatfield, Cambridge, Clinical Trials, Pharmaceutical, DQ & S, Clinical Data, Manager, Quality
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