TMF Document Specialist - FSP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel 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) within specified timelines, based on document criticality/priority

  • Communicate document inquiries with responsible users as needed

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

• Communicate and escalate issues to the TMF Document Specialist Lead and TMF Operations when needed

• Contribute to process improvement initiatives and projects that may arise

• Can be identified as Subject Matter Expert for TMF process, systems and related 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