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!
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.
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
Education
Minimum of a Bachelor’s degree or equivalent.
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
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