Summary
Overview
Work history
Education
Skills
Accomplishments
Timeline
Generic

Karuna VM

Bristol

Summary

Clinical Data & Research Analyst with extensive experience in clinical research and a Master's in Clinical Research and Regulatory Affairs. Proficient in managing clinical trial protocols and ensuring compliance with ICH/GCP guidelines. Demonstrated ability to analyse complex data and facilitate effective communication among stakeholders.

Overview

12
12
years of professional experience

Work history

Clinical Data Manager/ Analyst

IQVIA
Bristol, UK
05.2022 - 03.2025
  • Led a team to execute clinical data management tasks across multiple studies, ensuring timely data delivery and adherence to quality standards.
  • Developed essential project documentation, including data management plans, to guide compliance and project effectiveness.
  • Delegated data management activities to junior staff, ensuring adherence to quality and compliance standards.
  • Created study timelines and tracked milestones in collaboration with Senior CDM for timely data delivery.
  • Facilitated cross-functional communication through regular meetings, addressing data-related risks and supporting resolution strategies.
  • Managed data-related risks proactively, escalating critical issues and supporting resolution strategies.
  • Mentored junior Clinical Data Management colleagues on processes, tools, and procedures.
  • Demonstrated leadership by owning project-level activities to enhance study delivery.
  • Defined the scope and objectives of business systems through research and collaboration with stakeholders.
  • Analyzed user needs and adjust system logic to enhance efficiency and performance.
  • Oversee business systems projects from inception through implementation and support.
  • Designed PowerBI dashboards and functional prototypes to support data-driven requirements gathering.
  • Extracted, queried and interpreted complex lab data using SQL to inform clinical and operational decisions.
  • Translated technical infrastructure requirements into accessible documentation and actionable plans.
  • Reviewed peers work to ensure highest quality of output,.
  • Facilitated client meetings to discuss and interpret analysis findings.
  • Utilized data visualization tools to generate and deliver compelling presentations for internal an external stakeholders.

Senior Data Monitoring Coordinator

LabCorp
Bengaluru, India
09.2018 - 02.2022
  • Monitored clinical data quality and integrity across protocols, ensuring compliance with ICH-GCP, protocol requirements, and regulatory guidelines.
  • Managed vendor data feeds, performed data mapping, cleaning and resolved discrepancies to uphold protocol standards.
  • Mapped clinical data fields in GlobalCODE and conducted quality checks using STP and GSSops.
  • Investigated, documented and escalated data issues as needed, recommending process improvements and ensuring alignment with SOPs and validation requirements.
  • Prioritized tasks to meet TAT deadlines and supported successful Go-Live transitions.
  • Investigated and escalated data issues; proposed process improvements based on SOPs and validation standards.
  • Trained and mentored junior data managers and configuration associates; created training materials and updated procedural guidelines to support the Critical Specimen Monitoring team.
  • Led a new project on Prospective Specimen Monitoring, coordinating lab reports and team calls for status tracking.
  • Updated procedural guidelines and provided training for the Critical Specimen Monitoring team.
  • Represented the team in leadership meetings, delivering project updates and supporting process enhancements.

Clinical Process Associate II

Q2 Solutions
Bengaluru, India
03.2017 - 09.2018
  • Delegated as Clinical Process Associate for six studies, including two paediatric trials, ensuring seamless operations from Study initiation to closure.
  • Managed multiple Sponsors across varied complexity levels, delivering timely reports tailored to sponsor requirements.
  • Implemented effective query management and escalation pathways for prompt resolution, prioritizing patient safety.
  • Oversaw internal pending tests and coordinated lab testing schedules across regions, ensuring batch testing and stability checks.
  • Ensured data reconciliation and timely data transfer, maintaining vigilant follow-up with labs for test completion, sample tracking and disposal.
  • Sent Safety Reports within 24 hours and escalated issues to sponsors promptly for resolution.
  • Monitored study-related activities and managed queries daily to expedite report releases.
  • Conducted data validation and site loading as requested, with timely kit shipment orders and wastage monitoring.
  • Communicated daily with project managers and clinical coordinators, supporting study-related activities.
  • Trained and mentored new associates during transitional activities to ensure seamless integration.

Clinical Research Coordinator

Bangalore Clinisearch
Bengaluru, India
09.2013 - 03.2014
  • Served as Clinical Research Coordinator for Pre-Diabetic and Phase II Diabetic studies.
  • Managed daily trial activities to ensure successful completion.
  • Screened and recruited subjects, confirmed eligibility, and administered informed consent.
  • Coordinated study visits, testing, specimen procurement, and participant payments.
  • Drafted and submitted severe adverse event reports with MD signatures to sponsor and IRB.
  • Facilitated completion of clinical charts and case report forms ensuring data accuracy.
  • Designed source documents to optimize data capture during patient visits.
  • Maintained oversight of investigational product handling and accountability.
  • Utilized RAVE and MEDIDATA applications for Study management.
  • Communicated with patients regarding visit schedules and organized patient visit tracker.
  • Maintained temperature logs and assisted in informed consent administration.

Education

Master of Science - Clinical Research & Regulatory Affairs

Sikkim Manipal University
Bengaluru

Bachelor of Science - Biotechnology

Mount Carmel College
Bengaluru

Skills

  • Clinical Protocols
  • Advanced excel proficiency
  • Risk analysis techniques
  • Dataset analysis
  • Clinical Data Management Systems
  • Data visualization techniques
  • Risk analysis methods
  • SQL/SSMS data cleaning
  • Stakeholder Management & Workshop Facilitation
  • Microsoft Power BI

Accomplishments

  • Received recognition and accolades for collaborative efforts with the team during data analysis, requirements handover and testing phases, swiftly addressing identified defects.
  • Acknowledged for crafting comprehensive requirements, minimizing the need for repeated analysis and ensuring efficient workflow.
  • Have been awarded and received compliments from the Global Project Managers of the studies for supporting trials at various stages and for providing responses in a timely manner.
  • Received compliments for being available for closure of high number of queries and pending samples.
  • Received compliments from GPM for always being available to support and focus with any requests with a demanding trial and study

Timeline

Clinical Data Manager/ Analyst

IQVIA
05.2022 - 03.2025

Senior Data Monitoring Coordinator

LabCorp
09.2018 - 02.2022

Clinical Process Associate II

Q2 Solutions
03.2017 - 09.2018

Clinical Research Coordinator

Bangalore Clinisearch
09.2013 - 03.2014

Master of Science - Clinical Research & Regulatory Affairs

Sikkim Manipal University

Bachelor of Science - Biotechnology

Mount Carmel College

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Karuna VM