Job Title: E-Document Management Specialist
About the Role:
We are seeking an experienced E-Document Management Specialist to join our team. This role is responsible for ensuring data management and statistics trial documentation is managed according to internal standards and regulatory requirements.
Main 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 monitor TMF related activities using metrics to evaluate status and gaps to ensure quality and timelines and evaluate corrective actions
Key Skills and Qualifications:
* Scientific degree
* A significant experience in a similar job in the industry or CRO
* 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)
Other Requirements:
* 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