Hemalatha Lenin

As a TMF Lead, I manage TMF activities, ensuring compliance with client expectations and quality standards. I coordinate TMF milestones, provide training, and maintain proactive communication with clients. My role includes preparing for audits and inspections, and identifying process improvements.

In my role as TMF Reviewer, I ensure TMF compliance by conducting completeness checks and milestone reviews. I collaborate with the study team to maintain TMF quality and facilitate audits, while providing feedback for system enhancements.

As a Record Management Specialist, I ensured the accurate filing and retrieval of clinical trial documents. I managed document indexing in eTMF systems and coordinated communication regarding documentation progress.

In this role, I performed system administration for clinical trials, managed data entry, and trained new joiners on document processing. I ensured timely completion of study documentation and maintained processing metrics.

As a Senior QC Clinical Research Associate, I managed clinical trials, conducted quality control activities, and coordinated with QA teams. I was responsible for ensuring compliance with regulatory requirements and SOPs.

In my role as Clinical Research Coordinator, I assisted in data transfer, ensured protocol compliance, and managed documentation for clinical trials. I coordinated with vendors and maintained source documents.

As a Clinical Research Associate, I prepared protocols for clinical trials, coordinated with various departments, and ensured compliance with regulatory guidelines. I monitored studies and managed documentation.

In this role, I conducted site monitoring activities, ensured compliance with protocols, and trained study staff. I managed trial documentation and coordinated with investigators.

Completed a postgraduate diploma in Clinical Research Management and Regulatory Affairs.