Ruchita Sharma

Tmf Lead @ICON plc

Bengaluru, IN

Led the setup, maintenance, and close-out of study TMFs within the eTMF infrastructure, driving completeness, quality, and timeliness of TMF content for all assigned studies until close out.· Accountable for the development and review of the TMF Plan and study-specific TMF Index, ensuring alignment with SOPs and project/sponsor requirements.· Proactively reviewed the EDL & Placeholder list with the study team, conducted TMF Lead QC, and provided feedback to ensure all expected documents were present and completeness metrics were met.· Prepared and presented detailed monthly TMF metrics reports for multiple studies assessing completeness, quality, and timeliness to project leadership.· Served as primary contact for internal and external audits, managing audit responses and ensuring compliance with quality standards.· Managed team allocation, provided feedback, addressed escalations, and led training initiatives to enhance team capabilities. Managed ADHOC and stretch assignment based on Stakeholders priority.· Conducted TMF Lead QC reviews and collaborated with study teams to maintain document completeness and accuracy. Collaborated with Project Managers to remediate escalations.· Monitored study eTMF health and progress, reporting to Project Managers and Directors regularly.· Trained and developed eTMF expertise within TMF & study teams, promoting a culture of continuous improvement and delivery excellence.

CHHATTISGARH DENTAL COLLEGE AND RESEARCH INSTITUTE, SUNDARA

B. D. S., Dental Science

Cliniminds

PG Diploma in Clinical Research &Pharmacovigilance