Reviews documents for compliance with Good Document Practices and ALCOA+ standards.
Reviews the categorization of documents to confirm that they are filed in accordance with the DIA reference model and Allucent TMF Index.
Assess document metadata entered into the Veeva Vault system to verify that it reflects the study specific data entry instructions and is consistent with other documentation already present in the TMF.
Where documents do not meet required standards - accurately assesses issues and returns the document to the document owner or indexer as required.
Identifies trends in poor document completion and escalates these to the TMF Manager and TMF Lead as appropriate.
Participates in team meetings to review practices and improve knowledge of TMF documentation.
Mentors TMFS I.
Actively support to staff learning development within the company
Draft and contribute as Subject Matter Expert (SME) in the field of Trial Master File Specialist activities to the evaluation/improvement of processes and procedures within the Quality Management System.
Assure good communication and relationships with (future) clients
Contribute and take part in client evaluations and visits.
To be Life science, healthcare and/or business degree.
Minimum 3 years of relevant work experience processing documents within the TMF.
Minimum 4 years of experience in drug development and/or clinical research.
