Shweta Ghadse
Trial Master File Specialist at Biorasi
- Role
- Trial Master File Specialist at Biorasi at Biorasi
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Shweta Ghadse
An organized, goal oriented, proactive, full of enthusiasm experienced TMF Records…
Experience
Trial Master File Specialist at Biorasi
Aug 2022 — Present · Mumbai, IN
Scan, import, upload, code, and index documents into the electronic Trial Master File and review for quality on an ongoing basis• Review, classify and process Trial Master File (TMF) documents for multiple studies both in an electronic and hard copy format in a timely manner• Support the set-up, structure, maintenance, and closure of TMF.• Escalate any TMF Quality issues related to completeness and quality of documents (paper and electronic) in a timely manner to relevant parties• Prepare and transmit TMF and other critical documents to the Sponsor in accordance with the relevant instructions• Assists the Project Manager (PM), Clinical Trial Manager (CTM) and other functional leads (e.g, data management; biostats; medical writing, supply chain, etc.) to ensure TMF documentation is submitted/published in a timely manner and with high quality in order to maintain the TMF in an audit/inspection-ready state.• Attends internal project team meetings as applicable to the project.• Assists in preparing monthly TMF status, risks, issues and associated actions for assigned projects• 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.• Assist in providing regular feedback to the Project Team on TMF health/status, including actionable metrics.• Partake in regular team meeting/ teleconferences, as applicable.• Communicate any out-of-scope issues to upper management as soon as identified.• Assisting the study teams in meeting timelines.• Other duties as assigned.
Education
Ranibai Agnihotri College of Pharmacy
Master of Pharmacy, Pharmacology
Janata College
Intermediate
Indian Institute of Clinical Research and Management
Advanced Post Graduation Diploma in Clinical Research
Hi tech college of pharmacy chandrapur
Bachelor of Pharmacy - BPharm, Pharmacy
2012 — 2016
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