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. .
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Trial Master File Specialist Hiring at Biorasi | Apply for Hybrid Role in Mumbai[/caption]
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.
