Open To Work
JYOTHI C H
Senior Clinical Data Coordinator
Bangalore
Summary
Results-driven Clinical Data Management professional with 6.2+ years of experience in Clinical Data Management, Clinical Data Review, Query Management, Database Validation, SAE Reconciliation, and Database Lock activities across Phase I–III clinical trials. Hands-on experience working with global EDC platforms including Medidata Rave, Viedoc, Inform, iMedNet, Lambda Database, and JReview. Proven expertise in Study Start-up, Study Conduct, Data Cleaning, Discrepancy Management, UAT Testing, Metrics Reporting, Vendor Reconciliation, and Cross-functional Coordination. Skilled in leveraging AI productivity tools including ChatGPT, Perplexity AI, and Google AI for workflow optimization, clinical data review support, reporting efficiency, and documentation enhancement. Strong ability to deliver high-quality outputs within timelines while ensuring data integrity, compliance, and operational excellence.
Senior clinical data professional with demonstrated ability to manage, analyze, and interpret complex clinical data sets. Strong focus on team collaboration, adaptability, and achieving results. Skilled in data management, regulatory compliance, and clinical trial processes. Known for reliability, effective communication, and problem-solving capabilities.
Overview
6
6
years of professional experience
Work History
SENIOR CLINICAL DATA COORDINATOR
PRA Health Sciences
07.2021 - 09.2023
- Managed end-to-end clinical data management activities to ensure accurate, complete, and high-quality clinical databases.
- Performed query management, discrepancy review, and study listing activities in accordance with protocol requirements and project timelines.
- Conducted SAE reconciliation and vendor reconciliation activities to maintain data consistency and regulatory compliance.
- Collaborated with Study Data Managers, clinical teams, and cross-functional stakeholders during study meetings and operational discussions.
- Prepared and shared study metrics, status reports, and tracking reports with project teams and management.
- Planned and executed study-related data management activities aligned with sponsor requirements and project deliverables.
- Supported database review, validation, and study tracking activities to ensure timely study progression and database lock readiness.
- Contributed toward successful achievement of key study milestones including Interim Lock and Database Lock.
- Enhanced clinical data quality by implementing rigorous validation processes and procedures.
- Trained junior Clinical Data Coordinators, imparting valuable knowledge and expertise for their professional growth.
- Conducted thorough quality control checks on all collected data, resulting in improved overall data reliability.
- Resolved complex data discrepancies through detailed investigation and communication with various stakeholders.
- Reduced query resolution time significantly by proactively addressing potential issues during the CRF design phase.
- Maintained strong relationships with trial site staff, promoting a collaborative atmosphere to address any issues or concerns related to clinical data management.
- Utilized AI tools for workflow organization, reporting efficiency, documentation drafting, and productivity enhancement.
SENIOR CLINICAL DATA ASSOCIATE
Novotech
05.2017 - 05.2021
- Performed comprehensive clinical data management activities throughout the study lifecycle, including Study Start-up, Conduct, and Close-out.
- Conducted clinical data review and data cleaning activities in collaboration with medical and safety review teams.
- Reviewed discrepancies and generated queries to ensure data consistency, completeness, and protocol compliance.
- Contributed to CRF development, database testing, database validation, discrepancy management, and database lock activities.
- Expedited study timelines through proactive identification and resolution of data discrepancies.
- Conducted thorough quality control checks on completed datasets, ensuring the highest level of data integrity.
- Generated study metrics reports and shared operational updates with stakeholders and data managers.
- Generated study metrics reports and provided operational updates to stakeholders and data managers, facilitating informed decision-making.
- Worked as a Study Lead/Lead Data Manager for assigned projects, and supported coordination activities.
- Collaborated with cross-functional teams, fostering strong working relationships for seamless project execution.
- Trained junior associates on industry best practices, boosting overall team competency and productivity.
- Trained in Inform, and iMedNet database build and edit check programming.
- Supported database design and edit-check programming activities for iMedNet studies.
- Recognized as a reliable resource within the team due to my strong analytical skills and dedication to delivering high-quality results.
- Coordinated with site staff to address queries related to clinical data promptly, minimizing disruptions to study timelines.
- Conducted quality control checks on completed datasets, ensuring data integrity and adherence to study protocols.
- Participated actively in regular meetings with sponsors and stakeholders, maintaining clear communication lines throughout projects.
- Performed a comparison of the output review and provided feedback to the Data Managers for issue resolution.
- Participated in regular meetings with sponsors and stakeholders, fostering clear communication and alignment throughout project timelines.
Education
M.Tech - Biochemical Engineering
B.M.S College of Engineering
Bangalore01-2016
B.E - Biotechnology
BITM College
Ballari01-2014
Skills
Study Start-up, Conduct & Close-out activites
Clinical Data Review & Cleaning, Validation
Metrics Reporting & Study Tracking
Advanced Excel
Team leadership
Project prioritization
Time management
Excellent communication
Teamwork and collaboration
AI-assisted Workflow Optimization
Sponsor & Stakeholder Communication
Team Mentoring & Cross-functional Collaboration
Accomplishments
- Recipient of the “Novostars Award” for critical contribution toward achieving major milestones including Database Production, Interim Lock, and Database Lock activities within timelines.
- Recipient of the “Novoway Award” for playing a key role in successful Database Lock milestones for Regional Phase IIa Osteoarthritis and Global Phase III NSCLC studies.
- Received academic excellence award and certificate from Government of Karnataka during B.E studies.
Timeline
SENIOR CLINICAL DATA COORDINATOR
PRA Health Sciences
07.2021 - 09.2023
SENIOR CLINICAL DATA ASSOCIATE
Novotech
05.2017 - 05.2021
B.E - Biotechnology
BITM College
M.Tech - Biochemical Engineering
B.M.S College of Engineering