Job Description

Location Anywhere in India : Kolkata, Hyderabad/Secunderabad, Pune, Ahmedabad, Chennai, Delhi / NCR, Mumbai (All Areas)

JOB TITLE: Trial Master File (TMF) Document Specialist I

REPORTS TO: Manager, Trial Master File (TMF) Operations; or designee
 

JOB SUMMARY
Performs support tasks related to the set-up, maintenance and close out of the Trial Master File.

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%).

QUALIFICATION REQUIREMENTS:

• Must be a life science graduate with minimum 6 Months to 1 Year of relevant experience in TMF / Records management / Clinical Monitoring / Clinical Project Coordinator CTAs / CRCs / Quality & Research related roles
• 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.

Disclaimer:
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. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Skills Required: Health Care,Documentation,Clinical Research,Pharma,Biotech,Biotechnology,Medical,Pharmaceuticals,Medical Writing,Drug Regulatory Affairs