BHARATH PANDIT
Centralized Monitoring Lead
Bengaluru
Summary
Clinical Research Professional experienced in centralized data monitoring and clinical data analysis. Delivered improvements in patient safety oversight through comprehensive reviews of data listings and visualizations, identifying protocol deviations and safety concerns. Focused on enhancing data quality across multi-phase clinical trials while adapting to dynamic environments and managing project responsibilities effectively.
Overview
1
1
Language
2
2
Certifications
10
10
years of professional experience
Work History
Senior Associate Consultant – Clinical Research
Infosys Ltd.
09.2024 - 02.2026
- Data Analysis & Risk Signal Detection: Analysed clinical study data and KRI/QTL outputs using dashboards and visualization tools; identified protocol deviations, data integrity concerns and safety signals; escalated critical findings to study teams with supporting documentation and recommended corrective actions.
- Protocol Review & Patient Safety Assessment: Conducted protocol reviews to assess critical data and process risks; confirmed subject eligibility, identified protocol violations and associated patient safety concerns; documented observations in appropriate tracking systems.
- Query Development & Documentation: Wrote structured queries and action items based on identified data gaps, deviations or inconsistencies; maintained documentation of all observations and corrective actions in alignment with SOPs and ICH/GCP expectations.
- Dashboard & Analytics Tool Use: Worked with analytical dashboards and visualization tools to review patient data listings, perform trend analysis and identify data quality issues; proficient in interpreting visualizations to extract actionable insights.
- Led clinical trial design and execution, ensuring compliance with regulatory standards and protocols.
- Collaborated with cross-functional teams to streamline patient recruitment processes, improving timelines and efficiency.
- Developed and implemented monitoring plans to enhance data integrity and support risk-based approaches.
- Mentored junior consultants on best practices in clinical research methodologies and compliance requirements.
- Utilized electronic data capture systems to manage trial data, ensuring accuracy and timely reporting.
- Analyzed study data trends to identify potential issues and recommend proactive solutions.
- Coordinated project timelines and deliverables, enhancing team collaboration and optimizing resource allocation.
Clinical Data Management Scientist
Accenture
08.2022 - 01.2024
- Data Quality Review & Integrity Assessment: Conducted structured quality reviews of clinical datasets using data visualization approaches; identified illogical, inaccurate or missing data; assessed factors affecting data integrity at site level including protocol deviations and pharmacovigilance concerns.
- ETMF Data Completeness & Verification: Accessed vendor systems and eTMF platforms to verify investigational product dispensing, laboratory procedure completion and document status; ensured eTMF data was current and complete per protocol and regulatory expectations.
- Trend Analysis & Escalation Management: Performed trend analysis on study- and site-level data; escalated identified gaps and concerning findings to management; developed action plans with guidance from senior team members.
- Protocol Compliance & SOP Adherence: Maintained working knowledge of ICH/GCP Guidelines and company SOPs; structured all queries and documentation to ensure compliance with regulatory requirements and internal processes.
Centralized Monitor (promoted from Coordinator)
IQVIA
03.2018 - 08.2022
- Patient Data Monitoring & Protocol Deviation Identification: Reviewed patient data listings and visualizations via RBM/ARBM dashboards to identify protocol deviations, patient safety concerns, data integrity issues and missing/inaccurate data; confirmed subject eligibility and flagged illogical patterns for investigation.
- KRI/QTL Review & Signal Detection: Performed ongoing data surveillance and trend analysis using Key Risk Indicator (KRI) and Quality Tolerance Limit (QTL) outputs; identified anomalies, unusual patterns and risk signals; assessed their impact on patient safety and data quality.
- Site & Subject-Level Analysis: Conducted site-level and subject-level data reviews using analytical tools; documented observations via queries and action items; recommended targeted corrective actions including site interventions based on findings.
- Vendor System & IP Verification: Accessed clinical systems and vendor platforms (CTMS, EDC, IRT) to verify investigational product dispensing, laboratory procedure completion and data capture accuracy; ensured protocol compliance at site level.
- Query Writing & CRA Coordination: Wrote structured queries and protocol deviation documentation for sites and CRAs; tracked action item completion; maintained audit-ready documentation of all monitoring activities and findings.
- Multi-Phase Trial Experience: Gained hands-on exposure to Phase 1, 2 and 3 trials across cardiovascular disease, oncology and immunology; demonstrated ability to quickly adapt to therapeutic area-specific requirements and protocol nuances.
- Growth path: Centralized Monitoring Coordinator (Mar 2018 – Dec 2021) → Centralized Monitor (Jan 2022 – Aug 2022)
Junior Quality Analyst
Indegene Life Systems
10.2015 - 05.2016
- Data Quality Assessment & Compliance: Conducted structured quality reviews of clinical data and deliverables; identified deviations and gaps; documented findings and recommended corrective actions to improve accuracy and ensure alignment with quality standards.
Education
Clinical Research, Pharmacovigilance & CDM Course -
Indian Healthcare BPO
Bangalore01-2016
Bachelor of Education - undefined
R.V. Teacher's College
Bangalore01-2014
Master of Science - Applied Genetics
Bangalore University
Bengaluru, India 04.2001 -
B.Sc. - Chemistry, Biology & Zoology
National Degree College
Bangalore01-2011
Skills
Medidata RAVE
Veeva eTMF
CTMS
Protocol review
Documentation management
Risk Assessment
Query management
Data Integration
MS Excel (Advanced)
Power BI
SOP adherence
Trend analysis
Action tracking
Team Collaboration
Certification
Fundamental GCP Training Course (English 4.0 / 2.0) – 2020
Timeline
Senior Associate Consultant – Clinical Research
Infosys Ltd.
09.2024 - 02.2026
Clinical Data Management Scientist
Accenture
08.2022 - 01.2024
Centralized Monitor (promoted from Coordinator)
IQVIA
03.2018 - 08.2022
Junior Quality Analyst
Indegene Life Systems
10.2015 - 05.2016
Master of Science - Applied Genetics
Bangalore University
04.2001 -
B.Sc. - Chemistry, Biology & Zoology
National Degree College
Bachelor of Education - undefined
R.V. Teacher's College
Clinical Research, Pharmacovigilance & CDM Course -
Indian Healthcare BPO