Overview:
As a TMF Specialist you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities:
* 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.
Qualifications:
* 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.
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