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.

Your profile :
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.
You are 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 (recruitment@poxelpharma.com). 

All information required are necessary for Poxel, as data controller, to examine your application based on our legitimate interest in assessing your skills and aptitudes for the job. Failure to provide such information may prevent us from fulfilling your request.
Your personal data will be kept for a period of two (2) years after our last contact with you, except in the event of request for deletion of your file and, beyond, for a period not exceeding the applicable statute of limitation period.
Your personal data will not be transmitted or made accessible to any third party, except to Poxel’s authorized employees, its service providers for technical or logistical reasons only as well as recruitment agencies.
If any, your data may be transferred to a country located outside the European Union,  being specified that, in the event that the recipient country does not ensure a level of data protection equivalent to that of the European Union, Poxel undertakes to take all appropriate guarantees, either on the basis of an adequacy decision or, in the absence of such a decision, on the basis of appropriate guarantees, such as binding corporate rules or standard data protection clauses, the communication of which can be obtained by sending an e-mail to the address below.
In accordance with the applicable regulation, you have the right to access, rectify, delete, if any limit and ask for the portability of your personal data as well as a right to object to the processing. You may also define guidelines for the use of your personal data in the event of death. These rights can be exercised directly with us, at the following address: privacy@poxel.com. You also have the right to lodge a complaint at the relevant supervisory data protection authority.

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc