Swapnil Patil

• 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

Intern at site Punawale Multispeciality Hospital , Pune.

• Regulatory Compliance: Reviewed and analyzed regulatory documents (e.g., protocols, ICFs, IBs) to ensure adherence to ICH-GCP and local regulations
• Clinical Trial Management: Participated in study start-up activities, including site initiation visits and investigator training
• Data Management: Assisted in data cleaning, entry, and analysis to maintain data integrity and accuracy
• Clinical Trial Documentation: Prepared and maintained essential clinical trial documents, including case report forms (CRFs) and investigator site files
• Safety Monitoring: Supported safety reporting activities, including adverse event (AE) and serious adverse event (SAE) reporting
• Regulatory Submissions: Contributed to the preparation and submission of regulatory documents to regulatory authorities
• Patient Recruitment and Retention: Assisted in subject recruitment and retention activities
• Clinical Trial Monitoring: Participated in monitoring site visits to ensure compliance with protocol and regulatory standards
• Medical Record Review: Reviewed medical records to ensure accurate and complete documentation
• Inventory Management: Managed study drug inventory and accountability
• Electronic Data Capture (EDC): Utilized EDC systems for data entry and review