Syneos Health Hiring TMF Document Specialists - PHARMA STUFF

Syneos Health hiring TMF Document Specialists

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

Location: Asia Pacific-India
Job ID: 22008871

Description
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%).

Qualifications

What we’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, you’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
Syneos Health hiring TMF Document Specialists

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