Clinical Data Manager
Creation – Permanent contract
Reporting to Medical Director, Clinical Development, you will accountable for the data-management support for all Poxel’s preclinical and clinical studies (from Phase I up to phase III trials) in order to enhance POXEL’s expertise and efficiency.
Your main responsibilities are:
- Providing clinical data management support to Preclinical and Clinical Operations teams,
- Participating in the review of Clinical study documents (eg. Clinical trial Protocols, Clinical Study Reports),
- Contributing to EDC database specification process,
- Reviewing database (DB) and providing input in building the clinical trial data specifications, including eCRF design, user requirements, edit rules/check, query logic and data validations
- Reviewing Data Transfer Agreement(s) between external data vendors and/or core labs,
- Performing User Acceptance Test,
- Supporting the coordination and supervision of data management activities done by the CRO,
- Supporting the medical review
- Reviewing all data management documents during the study (eg : Data Management Plan, SDTM specifications),
- Supporting SAP and Mock TFLs review,
- Participating in data listing review,
- Ensuring clinical data within EDC has the appropriate quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock,
- Assisting in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
You have a Master Degree in relevant area (Data Management, Statistics or Biology/Biochemistry). You have a minimum of 3 years experience in Data Management in an international environment.
A working knowledge of Clinical data base applications such as EDC and CTMS are prioritary. SAS knowledge is a plus.
Your proactivity, your entrepreneurial spirit and your self-motivation skills will be a real asset to succeed in this position.
Fluent in English
Position based in Lyon office
Applications will be pre-screened and not all applicants may be included in the selection process
Candidates interested to apply may contact the HR team (email@example.com)
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