Trial Master File Specialist Hiring at Biorasi | Apply for Hybrid Role in Mumbai

Trial Master File Specialist Jobs at Biorasi

Are you ready to advance your career in clinical research? Biorasi, a leading global Clinical Research Organization (CRO), is hiring for the role of Trial Master File Specialist in Mumbai. This hybrid position is perfect for professionals with a background in clinical research and expertise in eTMF management. If you’re passionate about ensuring high-quality documentation in clinical trials, this opportunity is for you!

Trial Master File Specialist Job Description

Your Role

As a Trial Master File Specialist, you will play a critical role in managing, maintaining, and ensuring the accuracy of the Trial Master File (TMF) to meet industry and regulatory standards. Your responsibilities will include:

• Review, classify, and process Trial Master File (TMF) documents for multiple studies both in an electronic and hard copy format in a timely manner per the TMF plan and Biorasi SOPs
• Support for study et-up, structure, maintenance, closure, and transfer of TMF.
• Escalate any TMF related observations/issues regarding TMF health/status, including actionable metrics, completeness, and quality of documents electronic in a timely manner to Functional Leads. As necessary, support in providing re-training to the project team.
• Prepare and transmit TMF and other critical documents to the Sponsor in accordance with the relevant instructions.
• Prepare initial set up of Expected Document List (EDL) in eTMF System.
• Maintain System Access control throughout the study
• Assist the Project Manager, Clinical Trial Manager, and other functional leads (e.g., data management; biostats; medical writing, supply chain, etc.) to ensure TMF documentation is submitted/published according to study plan and with high quality in order to maintain TMF in an audit/inspection-ready state.
• Perform periodic TMF quality check as per SOP
• Attend internal project team and sponsor teleconferences as applicable to the project.
• Assist in training team members on TMF systems and study specific requirements.
• Plan, prepare and present monthly TMF status, risks, issues, and associated actions for assigned projects.
• Provide completeness & reconciliation reports to the project team
• May serve as back-up to TMF Associate
• Support the study team in the preparation, conduct, and follow up of internal and/or external audits/inspections.
• Archive all paper files and maintain an ongoing inventory list of all received files in timely manner.
• Partake in regular team meeting / teleconferences.
• Communicate any out-of-scope issues to upper management as soon as identified.
• Other duties as assigned.  .

Qualifications and Skills

To qualify for this position, you must have:

• Educational Background: A Bachelor’s Degree in a scientific discipline or equivalent work experience in the clinical research field.
• Experience:
  • Minimum five years of clinical research experience, with at least five years in eTMF management.
  • Knowledge of the Trial Master File Reference Model and records management best practices is preferred.
• Skills:
  • Proficiency in MS Office Suite (Word, PowerPoint, Excel).
  • Strong understanding of ICH GCP guidelines and relevant local regulations.
  • Data collection, indexing, and editing expertise.

How to Apply

Take the next step in your career by applying for the Trial Master File Specialist role at Biorasi. Submit your application today via the following link:
Apply Now

Applications are open for a limited time, so don’t miss this opportunity to join a leading global organization in the clinical research field.

Tagged as: Good Clinical Practice (GCP)