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Contenu de l'offre Senior Data Manager France chez Venn Life Sciences
“Our vision is to deliver results of the highest quality to our global sponsors on time and within budget. We do this through developing our staff to be world class in their fields and forming real, lasting relationships with our clients.”
We are currently looking for an experienced Data Manager to join our team in Paris offices.
This role is responsible for data management activities for clinical interventional or non-interventional studies ensuring high quality, timely and cost effective delivery of the data management elements of projects.
Responsibilities & Accountabilities
Liaise between Venn Life Sciences, the sponsor and other 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
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)
Participate in the writing and updating of data-management SOPs, forms and templates
Key Capabilities Required
Qualifications & 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.
Skills
Good organizational and interpersonal skills with the ability to work diligently, accurately and under pressure, alone and/or as part of a team
Excellent time management skills
Ability to multi-task, skill in establishing priorities and managing workloads
Service oriented
Ability to establish and maintain effective working relationships with co-workers, managers and clients
Ability to be flexible and to adapt and work effectively with a variety of situations or individuals
Professional who is experienced and dependable with discretion, integrity, enthusiasm and a positive attitude.
Excellent computer skills including proficiency in use of Microsoft Office Tools, knowledge of and proficiency in SAS desirable but not essential
Excellent writing and verbal communication skills including fluency in English (additional language skills desirable)
Salary scale is €40-€50,000 per annum depending on experience.
If you are interested in this role, please email your to your CV to Gaëlle Mallet – gaelle.malet@venncro.com.