TMF Specilaist

As a TMF Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

• Ensure consistent receipt, analysis, classification, registration and /filing/retrieval of electronic clinical trial essential and non-essential documents and other clinical trial related documents.
• Indexing of documents in eTMF Veeva Vault with the required metadata.
• Perform peer review and ensure that the document is in final state.
• Send rejection information using Microsoft form and notify sender via email.
• Run inactivation/reclassification reports and complete tasks as needs needed
• Coordinate communications regarding progress and completion of study documentation, package creation and data entry activities to the various functional areas as appropriate.
• Run and analyze reports.
• Maintain weekly document processing metrics/errors/returns/delays for department - excel spreadsheet.
• Oversee processing of study document requests from cross-functional team members ensuring all urgent requests and inquiries are addressed on time for all studies.
• Providing process training and mentoring to new RMSs.
• Provide QC and audit support.
• Coordinate, lead and execute tasks, Weekly submissions error reconciliationprocesses and report on completion and error metrics.
• Coordinate, lead and execute QC process as per sponsor QCP, report on quality metrics of team & individuals and communicate with team on error-treanalysis and QC metrics.
• Monitor/track and report on the reworks/reclassification requests.

• 2+ to 4 Years’ experience in Pharmaceutical or Contract Research Organization.
• Ability to interact with Clinical and Regulatory team regarding the receipt, analysis, classification and disposition of documents.
• Demonstrated knowledge of “Essential” Clinical Trial Documentation.
• Good verbal and written communication skills (English and local).
• Demonstrated attention to detail and ability to multi-task.
• Demonstrated problem solving, time management, and organizational skills.