Nayana Sanket Ghorpade
Navi Mumbai,Maharashtra
Summary
Dynamic eTMF Document Specialist & Clinical record Management associate at Tata Consultancy Services with proven expertise in TMF quality control and regulatory compliance. Adept at managing end-to-end TMF transfers and resolving discrepancies through effective CRO communication. Recognised for maintaining audit readiness and utilising advanced Excel tools to enhance document tracking and quality assurance.
Overview
11
11
years of professional experience
Work History
eTMF Document Specialist
Tata Consultancy Services
09.2022 - Current
- I closely work with the cross functional teams of Clinical Research Organization (CRO), and the Clinical Record Management associate.
- Coordinated cross-departmental documentation processes, ensuring compliance with company standards and regulations.
- Perform QC of study documents using the Clinical Veeva Vault and D2 platforms.
- Conduct completeness checks, and validate metadata to ensure TMF inspection readiness.
- Upload and index documents in Clinical Veeva Vault and One Archive, with strict compliance to standards.
- Communicate with internal teams and CROs to resolve discrepancies, metadata errors, or quality issues.
- Lead CRO TMF transfer activities from initiation to final archival, including document reconciliation, tracking, and final TMF upload.
- Engage in document retrieval processes, and manage the end-to-end TMF archival lifecycle.
- Utilize Excel-based tools for document QC, tracking progress, and maintaining audit trails.
- Act as a process trainer, quality checker (QCer), and primary point of contact for CRO TMF transfer queries.
- Support internal and external inspections by preparing documents and resolving findings.
- Ensure TMF documentation aligns with SOPs, study-specific TMF Index, and regulatory standards.
- Streamlined document workflows, reducing processing time and improving accuracy across projects.
- Trained team members on best practices for document handling and system navigation, fostering a culture of continuous improvement.
- Analyzed existing documentation procedures, identifying opportunities for optimization and implementing effective solutions.
- Collaborated with stakeholders to gather requirements for new documentation systems, aligning outcomes with organizational goals.
- Managed version control for critical documents, ensuring all team members had access to the most current information.
- Performed regular audits of document repositories, ensuring the accuracy and integrity of all stored information.
- Managed high volumes of documents efficiently, prioritizing tasks according to deadlines and project requirements.
- Safeguarded sensitive information by adhering to strict security protocols when handling confidential documents.
- Prepared digital files and work requests in compliance with company guidelines.
- Ensured compliance with company policies and industry standards, maintaining meticulous attention to detail in all document-related tasks.
- Facilitated seamless communication between departments by acting as a liaison for document-related inquiries and requests.
- Elevated team morale and productivity through active participation in collaborative brainstorming sessions focused on improving document-related processes.
Field Officer
KEM Hospital
Mumbai
09.2018 - 08.2022
- Executed large-scale data collection across multiple healthcare sites.
- Validated, managed, and reconciled data to ensure consistency and accuracy.
- Ensured timely documentation and proper study filing across project phases.
- Project: Costing of Health Care Services in Different States of India
Research Fellow
Tata Memorial Hospital
11.2014 - 05.2018
- Collected, validated, and managed study data in accordance with GCP and study protocols.
- Conducted patient enrollment activities and obtained informed consent.
- Educated participants regarding study participation and protocol compliance.
- Handled, labeled, and managed biological samples as per SOPs.
- Maintained study documentation and compiled IRB (ethics) documents.
- Ensured accurate filing and storage of study documents for audit readiness.
- Project: MOBI-KIDS – Risk of Brain Cancer from RF Exposure in Childhood & Adolescence
Education
Master - Botany (cytogenetic molecular biology and biotechnology)
The Institute Of Science Mumbai
01.2014
Bachelor - Botany
Ismail Yusuf College
01.2013
Higher Secondary - Science
S.V.T College
01.2009
Senior Secondary -
A.G.H.S
01.2007
Skills
- eTMF
- TMF QC
- Document Filing
- Metadata Verification
- Inspection Readiness
- Archival
- Veeva Vault
- D2
- One Archive
- SharePoint
- CTMS
- Microsoft Excel
- BOX
- ICH-GCP
- SOP Adherence
- Regulatory Compliance
- KPI Monitoring
- Audit Support
- Interim Exports
- CRO Collaboration
- TMF Transfer
- Document Tracking
- Study Closeout
- Checklist Creation
- Stakeholder Support
- Excellent written and verbal communication skills
- Strong presentation skills
- Ability to prioritize tasks and manage time effectively
- Collaborative approach to working in team environments
- Teamwork orientation
- Recordkeeping skills
- File management
- Document management
Languages
English
Marathi
Hindi
Personal Information
Date of Birth: 23 November 1991
Disclaimer
I hereby declare that the above information provided by me is true to the best of my knowledge.
Timeline
eTMF Document Specialist
Tata Consultancy Services
09.2022 - Current
Field Officer
KEM Hospital
09.2018 - 08.2022
Research Fellow
Tata Memorial Hospital
11.2014 - 05.2018
Master - Botany (cytogenetic molecular biology and biotechnology)
The Institute Of Science Mumbai
Bachelor - Botany
Ismail Yusuf College
Higher Secondary - Science
S.V.T College
Senior Secondary -
A.G.H.S
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