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.