Job Title: eTMF Documentation Manager
About the Role:
We are seeking a highly skilled eTMF Documentation Manager to join our team. As an eTMF Documentation Manager, you will be responsible for ensuring data management and statistics trial documentation is managed according to internal standards and regulatory requirements.
Responsibilities:
* To oversee activities to ensure TMF documentation is published in a timely manner and with high quality in order to maintain TMF in an inspection and audit readiness
* To lead the Documentation and Data Archiving team providing subject matter expertise and guidance to team members
* To ensure providers match performance expectations
* To promote optimal use of tools and metrics related to documentation management
Key Responsibilities:
* To lead the documentation and data archiving team, recruiting, mentoring and developing the team
* To train DM/STAT CRO on Company standards and TMF related activity
* To monitor TMF related activities using metrics to evaluate status and gaps to ensure quality and timelines and evaluate corrective actions
* To support team members in the TMF plan activities and quality checks
* To participate to audit and inspection to TMF
* To perform regular checks on data archiving activities to ensure timelines are respected
* To contribute to eTMF process improvement and internal system development
Requirements and Skills:
* Scientific degree
* A significant experience in a similar job in the industry or CRO
* Knowledge of drug development process
* Solid knowledge of clinical data management and statistical process and related documentation, standards and tools
* Strong knowledge of international standards for Trial Master File (TMF Reference Model)
* Knowledge of ICH GCP and regulatory requirements with specific reference to data integrity, data archiving and document management
* Good knowledge of SAS System
* Knowledge of international data standards (CDISC) and regulatory requirements for data submission
* Project and budget management
* English knowledge
* eTMF - EDMS - SAS System
Type of Contract:
Maternity replacement
Chemical contract
IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request.