Syneos Health hiring TMF Document Specialists

syneos health hiring tmf documentation specialist7576318247923123068

Syneos Health Looking for TMF Document Specialist I (12 Month Contractual role)

Location: Asia Pacific-India
Job ID: 22008871

Trial Master File (TMF) Document Specialist

Job responsibilities

  • Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific TMF Plans.
  • Support the set-up, maintenance, and closure of TMF repositories.
  • Support documentation collection activities, including:
  • Document scanning and indexing for trial using an electronic TMF
  • Document filing for trials using a paper TMF
  • Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified
  • Maintain compliance with departmental quality, performance and utilization targets
  • Complete administrative tasks (e.g., status reports) as requested
  • Maintain compliance with company requirements (e.g., time tracking, training)
  • Participates in preparation/reconciliation of TMF documentation related to audits, inspections and shipments.
  • Participates in study specific training as required.
  • For Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return.
  • Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room
  • Ensures the security and compliance of all documents related to active and archived projects
  • Performs other work-related duties as assigned. Occasional travel may be required (up to 10%).


What weโ€™re looking for

  • High school education, some college courses in the scientific/regulatory field preferred.
  • Some experience in a clinical trials environment preferred.
  • Some knowledge of applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology preferred.
  • Familiarity with electronic TMF system preferred. Strong verbal, written and organizational skills with a team-oriented approach.
  • Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment.
  • Proficiency in Microsoft Office Suite and Adobe Acrobat

Get to know Syneos Health

  • Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
  • No matter what your role is, youโ€™ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment

Additional Information:

  • Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
  • The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
  • Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
  • The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
syneos health hiring tmf documentation specialist7576318247923123068
Syneos Health hiring TMF Document Specialists

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