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.
