Senior Data Manager - Paris

C.K. Associates Limited
Paris Island Little
45000 to 55000
05 Oct 2017
07 Nov 2017
Contract Type
Full Time
Jenni Woolley is recruiting for a Senior Data Manager to join a Contract Research Organisation at their site based in Paris on a permanent basis. The main purpose of the role will be to § Conduct DM activities: § Prepare Data Management Plan § Lead the CRF and database design activities, in collaboration with other internal and external partners (PM, CRA, statisticians, medical experts) § Prepare clinical data management documents (Annotated CRF, data-entry guidelines/eCRF user guide, Edit Checks plan, Coding conventions, Deviation list, Data Review plan, Data review minutes) ensuring appropriate quality, content and compliance with regulatory guidelines and company/Sponsor's SOPs. § Program, test or validate the Edit Checks programs using CDMS Viedoc, Marvin and SAS § Program specific data listings, patient profiles and deviations listings § Query management § Ensure the automatic coding and first manual coding of medical data § Prepare, participate and write the minutes of the Blind Review Meeting § Prepare and validate submission datasets and documentation for regulatory submissions (SDTM) Further responsibilities will include: § Liaise between internal and external partners to establish, align and confirm data management expectations for the assigned trial. § Serve as the Data-management representative on assigned project teams, providing proactive support to Project Management for planning efficient work plans and timelines for data-management activities and deliverables, and data-management input into other departmental deliverables. § Plan and track content, format, quality, and timing of data management deliverables § Ensure continuous, accurate and transparent reporting of data management activities § Participate in internal and external project/team meetings § Participate in the writing and updating of data-management SOPs, forms and templates In order to be considered for this role, you will be required to have the following qualifications, skills and experience: § Science and/or medical/pharmaceutical/or nursing and/or computer background, or specific data-management degree § Computer or scientific training/diploma § Previous experience of at least three to four years in the practice of Clinical Data Management and programming related to database management in a CRO or bio/pharmaceutical setting with experience in all the aspects of data-management activities for a clinical trial (including database design, programming and data-cleaning) § Knowledge of current regulatory regulations, GCP, ICH guidelines in clinical trials, 21-CFR part 11 and other relevant regulatory requirements § Knowledge of CDISC standards (CDASH/SDTM), and coding dictionaries (MedDRA and WHO-Drug) § Previous experience of at least one EDC/eCRF system. § Excellent computer skills including proficiency in use of Microsoft Office Tools, knowledge of and proficiency in SAS desirable but not essential This is an excellent opportunity to join a global CRO who specialise in providing drug development. clinical trial management and resourcing solutions to pharmaceutical biotechnology, medical device and academic organisations. 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 CL40118 in all correspondence.
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