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
- 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 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
- 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.