TMF/Clinical Document Specialist

Creation – Permanent contract – Full time
Reporting to the Director, Clinical Operations you will be accountable for managing quality check and inspection readiness of (e)TMFs of several phase 1/2 studies for the Sponsor.


Your main responsibilities are:

  • (e)TMF/ TMF QC
Reviewing and performing quality checks (QC) of (e)Trial Master File of completed and ongoing clinical studies (mainly Phase 1 studies) to identify any filing issues,
Preparing QC reports and working in collaboration with the CROs to compile any missing documents and resolve the QC   findings.
  • Scan & indexation into the (e)TMF
Ensuring paper trial documents are scanned and indexed into the (e)TMF,
Participating to the organization of paper documentation scanning process and checking that all scanned documents are   accurately identified, filed and easily retrieved,
Ensuring that scanned documents are quality checked and conformed to the original paper documents,
Preparing study-specific checklist of all paper and electronic clinical documents.
  • Internal support in TMF filing and archiving
 Critical reviewing of the e(TMF) plan per study,
Preparing the Poxel documents for integration into each TMF per study,
Managing (e)TMF returns at Poxel before archiving,
Managing the archiving of e(TMF)s documentation related to clinical activities,
Supporting the Chemistry Manufacturing Controls department for filing and archiving of documentation related to Investigational Medicinal Product. 
  • Transfer to Japanese partner

Participating to electronic transfer of each (e)TMF to our Japanese partner.

  • Support in the preparation of the PMDA inspection
Ensuring Japanese regulatory (PMDA) inspection-readiness of the (e)TMF,
Supporting the clinical trial teams in the preparation of the PMDA inspections.


Your
profile :
  

You have at least a Bachelor degree of Science (BSc) or Administration.
You have excellent command of French and English.
You have a minimum of 2-3 years experiences in a pharmaceutical company or CRO as Clinical Research Associate or TMF specialist.
You have a strong understanding of TMF set-up, maintenance and quality review and a strong knowledge of TMF regulatory requirements and GCP/ICH guidelines.
You have experience in document management and in collecting, scanning, filing and archiving clinical documents.
Pro-active, you have excellent organization and time-management skills and a strong attention to details.
You can work independently and as part of the team and you have a strong ability to prioritize workload.


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