Sreenivasulu Talari
Bengaluru
Summary
Clinical Research Specialist with over 3.5 years of experience in managing multi-country Phase II and Phase III clinical trials. Expertise in centralized monitoring, remote site management, regulatory compliance, and global stakeholder coordination. Skilled in trial documentation, risk-based monitoring, and leveraging eClinical tools (EDC, CTMS, eTMF) to ensure seamless trial operations. Seeking to contribute my trial expertise and operational excellence to drive successful clinical studies.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Associate Centralized Monitor
IQVIA
Bengalore
2024.02 - Current
- Study Management: Managed assigned studies with minimal supervision, ensuring accurate completion and maintenance of internal systems, databases, tracking tools, timelines, and project plans.
- 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.
- Communication: Established and maintained effective project/site communications, acting as the point of contact for assigned deliverables for specific customers or projects.
- Operational Insight: Managed the operational insight of the assigned project(s), including trend analysis of clinical aspects of the trial, review of clinical study alerts, and monitoring of clinical operation plan compliance.
- Site Evaluation: Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol, and adherence to applicable regulations.
- Quality Risk Oversight: Monitored QTL and KRI while assessing historical site performance per Trial Monitoring Plan (TMP), ensuring rigorous quality risk management(RBQM).
- eTMF & ICF Oversight: Managed eTMF and ICF processes, ensuring precise tracking, filing, and regulatory compliance.
- Data Management: Utilized advanced analytics to extract study-level insights from subject-level data, ensuring regulatory compliance through trend identification and protocol deviation detection.
- Data Review: Performed subject-level data review that required further investigation with the clinical site to determine overall accuracy.
- Study Reporting & Site Support: Provided study performance updates from a global to local scale,and managed the entire site lifecycle from activation to close-out.
Clinical Research Associate -1
Litemed India Pvt Ltd
Bengalore
2022.05 - 2023.07
- Study Managment: Coordinate the ongoing clinical studies. Follow up with the Pls, and regular meeting with the team to track the progress.
- Document Preparation: Designed the new clinical studies, research protocols, and clinical research documents.
- Site Visits: Conducted site qualification, site initiation, and site monitoring visits.
- Trial Monitoring: Verify the data on eCRFs, site master file, IP, trial supplies, AES, and SAEs reports.
- Essential Documents Review:Reviewed & tracked essential regulatory documents and interacted with sites to resolve outstanding issues including submission of fi nal document to eTMF.
- Ethics Committee and Regulatory Submission Management: Timely preparing, notification, and tracking of the Ethics Committee and Regulatory submissions.
Clinical Trial Coordinator
Biofi Health Care India Pvt Ltd
Bengalore
2021.08 - 2022.04
- Clinical Trial Documentation: Writing or contributed to the preparation of clinical trial protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical trial documents.
- ICF Consent Process: Assisted in ICF process, screening, and patient enrollment, collected and recorded adverse events.
- Data entry & accountability: Accountable for timely and accurate entry of information on source documents, paper case report forms (CRFs), insisting on proper study product storage and accountability.
- Timely Submission of Study Updates and Safety Reports: Submitted the study progress, amendments, protocol deviations, AES, and SAEs to the Ethical committee and sponsor in a timely manner.
Education
Doctor of Pharmacy -
Santhiram College of Pharmacy
03.2021
Skills
- Clinical Trial Management Systems (CTMS) – Oracle & Veeva vault
- Electronic Data Capture (EDC) - iMedidata
- eTMF - Veeva Vault
- Remote Data Review Tools - PDMS
- Randomization and Trial Supply Management Systems (RTSM) - ALMAC IxRS
- MS Office Suite - Word, Excel, PowerPoint
Accomplishments
- Employee of the year award (Litemed/ 2022) for exceptional work and contribution to the company whole year.
- Ovation Award (2024)-IQVIA for proactive approach to work and the insights you provided to the client during study meeting.
Certification
- 1) Completed the Advanced P.G Diploma course in Clinical Research and Pharmacovigilance at Clinosoft Research.
- 2) Completed the certification of "Good Clinical Practice" conducted by NIDA clinical trials network.
Timeline
Associate Centralized Monitor
IQVIA
2024.02 - Current
Clinical Research Associate -1
Litemed India Pvt Ltd
2022.05 - 2023.07
Clinical Trial Coordinator
Biofi Health Care India Pvt Ltd
2021.08 - 2022.04
Doctor of Pharmacy -
Santhiram College of Pharmacy