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:
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 (email@example.com).
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