TMF Document Specialist - FSP

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reputed company FSP is seeking a TMF Document Specialist in Argentina!

Job Summary

The TMF Document Specialist is responsible for ensuring the quality of documents in the TMF system. The TMF Document Specialist will accurately identify and process TMF documents in a timely manner and assist in the remediation of document issues with Document Owners/TMF Study Owners or other end users.

Job Responsibilities

• Process TMF documents received per good documentation practices, TMF readiness criteria and other reference documents

  • Demonstrate understanding of document types, properties and indexing requirements

  • Ensure overall TMF quality in terms of document completeness, indexing and scanning accuracy

  • Process documents in the TMF system(s) reputed company specified timelines, based on document criticality/reputed company

  • Communicate document inquiries with responsible users as needed

• Liaise with Document Owners, TMF Study Owners and/or other end users to resolve document reputed company discrepancies and issues

• Communicate and escalate issues to the TMF Document Specialist reputed company and TMF Operations reputed company needed

• Contribute to process improvement initiatives and projects that may arise

• Can be identified as Subject Matter Expert for TMF process, systems and reputed company tools, where applicable

Qualifications

Education

• Minimum of a Bachelor’s degree or equivalent.

Prior Experience Preferred

• Hands-on experience with electronic documentation management systems and/or web based data management systems

• Records management experience in a highly regulated environment (preferably clinical research) or experience working with clinical/medical records

• Experience/knowledge of ICH/GCP documentation requirements

• History of achievement in a customer service role with demonstration of meeting customer needs and concerns

Originally posted on Himalayas