Swapnil Patil
eTMF Specialist
Pune
Summary
Accomplished Clinical Document Specialist from TransPerfect, adept in eTMF Management and fostering client relations. Excelled in enhancing audit readiness and regulatory compliance, significantly improving project delivery. Skilled in leveraging Veeva Vault and Trial Interactive, demonstrating exceptional project coordination and stakeholder communication. Proven track record in driving cross-functional team collaboration and delivering results beyond expectations.
Overview
2
2
years of professional experience
Work History
Clinical Document Specialist
TransPerfect
09.2022 - Current
- Conducted thorough review and initial indexing of study documentation for Trial Master File (TMF) quality in sponsor and CRO studies.
- Managed and updated study-specific trackers, communicating progress and updates to project leads.
- Facilitated prompt responses to Q&As in project rooms, ensuring timelines were met.
- Attended regular meetings with project managers and clients to discuss project status and resolve issues.
- Coordinated with Clinical Document Leads to address project-related queries, maintaining smooth workflow.
- Monitored and resolved documents in clarification and rejection status, ensuring accurate and timely updates.
- Reviewed monthly reports for clarification and rejection before submission to clients, maintaining high quality standards.
- Kept project mappings current, coordinating with study leads to implement required changes.
- Performed internal reviews of eTMFs to ensure audit readiness, leading to successful compliance outcomes.
- Assisted with User Acceptance Testing (UAT) during product development and release phases.
- Collaborated with cross-functional teams, including Project Management, Business Development, and IT, to implement and manage client projects.
- Provided ongoing feedback to the Development Team, contributing to continuous improvement of product features and functionalities.
- Served as a key member of the Project Team, driving project success through expert knowledge of the TMF Reference Model and Trial Interactive features.
- Proactively learned about clients' industries and needs, identifying new business opportunities and enhancing client service delivery.
- Set and consistently met client expectations, ensuring high satisfaction levels.
- Took on additional special projects and duties as assigned, demonstrating adaptability and commitment to the team’s success.
Education
Bachelor of Pharmacy -
North Maharashtra University
Jalgaon, India 04.2001 -
Skills
Technical Skills
- eTMF Management
- Quality Assurance (QA)
- Audit Readiness
- Regulatory Compliance
- TMF Reference Model Expertise
- Clinical Documentation Management
Project Management Skills
- Project Coordination
- Stakeholder Communication
- Meeting Facilitation
- Timeline Management
- Task Prioritization
Interpersonal Skills
- Cross-Functional Team Collaboration
- Client Relations Management
- Problem-Solving
- Proactive Learning and Adaptability
- Expectation Management
Software and Tools
- Veeva Vault
- Trial Interactive
- Microsoft Office Suite (Excel, Word, PowerPoint)
Timeline
Clinical Document Specialist
TransPerfect
09.2022 - Current
Bachelor of Pharmacy -
North Maharashtra University
04.2001 -
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