Job Overview
We are seeking a highly skilled eTMF Specialist to join our dynamic team. This individual will be responsible for managing data management and statistics trial documentation, ensuring it meets internal standards and regulatory requirements.
Key Responsibilities:
* To oversee the timely publication of TMF documentation with high quality 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
Requirements and Qualifications:
* 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 language proficiency
* eTMF - EDMS - SAS System
Type of Contract:
Maternity replacement contract