Dr S.N. Dharun Babu Email & Phone Number

Bengaluru, Ka, In

Bengaluru, Karnataka, India

1)Team Collaboration: Participated in team meetings, implemented action items, and provided inputs to clinical study teams, key decision makers,and internal team members to manage continuous process improvements and issue escalation.2)Communication: Established and maintained effective project/site communications, acting as the point of contact for assigned deliverables forspecific customers or projects.3)Operational Insight: Managed the operational insight of the assigned project(s), including trend analysis of clinical aspects of the trial, reviewof clinical study alerts, and monitoring of clinical operation plan compliance.4)Site Evaluation: Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence toapplicable regulations.5)Quality Risk Oversight: Monitored QTL and KRI while assessing historical site performance per Trial Monitoring Plan (TMP), ensuring rigorousquality risk management.6)eTMF & ICF Oversight: Managed eTMF and ICF processes, ensuring precise tracking, filing, and regulatory compliance.7)Data Management: Utilized advanced analytics to extract study-level insights from subject-level data, ensuring regulatory compliance throughtrend identification and protocol deviation detection.8)Essential Documents Review: Reviewed & tracked essential regulatory documents and interacted with sites to resolve outstanding issuesincluding submission of final document to eTMF.9)Data Review: Performed Subject Level Data Review that required further investigation with the clinical site to determine overall accuracy.10)Documentation: Ensured complete and accurate documentation of all study-specific tools and templates, keeping the project audit-ready.11)Study Reporting & Site Support: Provided study performance updates from a global to local scale, and managed the entire site lifecycle fromactivation to close-out.

Chennai, Tamil Nadu, India

1)Submitted trial related SAE to DCGI (via Sugam portal), Sponsor, Ethics committee and Head of institution.2)Working knowledge in preparing study start up documents to Sponsors, Ethics committee and attended SIV and Site close out visit by sponsorsand archival of trial documents.3)Working knowledge in preparing and maintaining Site Master File or Investigator Site File.Notify all the study related documents to Ethics committee.4)Accompanied in onsite monitoring visits and remote monitoring visits by sponsor.Monitoring the Pharmacist and Lab technician for maintaining IP temperature and sample storage according to study protocol to avoidtemperature excursion.5)Working knowledge in submitting trial documents to e-IRB for approval and notifications.Record all the study related documents in CRF and eCRF and query resolution.6)Maintaining all the study related logs to document in SMF7)Design and maintain source documentation based on protocol requirements.8)Monitor subject safety and report adverse drug reaction to appropriate medical personnel.

1)Served as Clinical Research Coordinator for 04 studies in various departments (Cardiology, Vaccines, Surgical and General Medicine)2)Submitted trial related SAE to DCGI (via Sugam portal), Sponsor, Ethics committee and Head of institution.3)Working knowledge in preparing study start up documents to Sponsors, Ethics committee and attended SIV and Site close out visit by sponsorsand archival of trial documents.4)Working knowledge in preparing and maintaining Site Master File or Investigator Site File.Notify all the study related documents to Ethics committee.5)Accompanied in onsite monitoring visits and remote monitoring visits by sponsor.6)Monitoring the Pharmacist and Lab technician for maintaining IP temperature and sample storage according to study protocol to avoidtemperature excursion.7)Working knowledge in submitting trial documents to e-IRB for approval and notifications.8)Record all the study related documents in CRF and eCRF and query resolution.9)Maintaining all the study related logs to document in SMF10)Design and maintain source documentation based on protocol requirements.11)Monitor subject safety and report adverse drug reaction to appropriate medical personnel.

Chennai, Tamil Nadu, India