TMF Specialist, Safety Processing – Min 2 Years of Experience in Central File Management

Location

Argentina

Posted

20 hours ago

Salary

0

Seniority

Mid Level

Bachelor Degree2 yrs expEnglishGoogle Cloud Platform

Job Description

TMF Specialist, Safety Processing – Min 2 Years of Experience in Central File Management

Syneos Health

• Process TMF documents received per good documentation practices • 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 • 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

Job Requirements

  • Minimum of a Bachelor’s degree or equivalent
  • Minimum of 2 years of relevant experience in central file management for clinical trials
  • Experience in the pharmaceutical industry or at a CRO in a similar role
  • Experience working in a global environment
  • Solid knowledge of ICH/GCP documents requirements
  • Effective verbal and written communication skills
  • Strong technical proficiency and the ability to learn and use various systems

Benefits

  • career development and progression
  • supportive and engaged line management
  • technical and therapeutic area training
  • peer recognition and total rewards program

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