Jagani Prabu
Littlehampton,United Kingdom
Summary
Accomplished Clinical Research Professional with over 4 years of experience across clinical trial execution, clinical data quality management, protocol compliance, and site documentation in CRO, sponsor, and research site environments. Proven expertise in ongoing clinical data review, identifying data discrepancies, and executing end-to-end query management in EDC systems (Medidata Rave, Inform, REDCap). Possesses a strong scientific foundation (MSc Pharmacology, Diploma in Clinical Data Management) and deep knowledge of ICH-GCP, ALCOA++ data integrity principles, safety data.
Overview
1
1
Certification
14
14
years of professional experience
Work History
Study Document Associate
Allergy Therapeutics
09.2025 - 09.2026
- Conducted rigorous quality and compliance reviews of clinical trial data and documentation in accordance with trial plans, SOPs, and GCP guidelines.
- Identified missing, incomplete, or non-compliant clinical data and trial records across study databases using ALCOA++ principles, enhancing data integrity and compliance.
- Performed risk-based data and document reviews, supporting the early identification and resolution of potential study risks and protocol deviations.
- Coordinated with study teams and document owners to implement corrective actions, tracking issue resolution to ensure ongoing inspection readiness.
Clinical Trial Associate
Research Organization (KC) Ltd.
12.2024 - 04.2025
- Conducted second-level quality control (QC) and completeness reviews on clinical study datasets and trial records, ensuring data integrity and compliance.
- Evaluated trial data against ICH-GCP standards and sponsor SOPs to identify documentation and compliance risks, enhancing regulatory adherence.
- Collaborated with multidisciplinary study teams to resolve rejected data entries and metadata discrepancies, improving data accuracy and completeness.
Clinical Data Compliance Coordinator
Synexus Midlands (Thermo Fisher Scientific)
04.2023 - 06.2024
- Executed data quality and documentation tracking across multiple concurrent clinical trials, ensuring source data integrity and timeliness.
- Cross-checked site data entries and essential records to perform quality checks and identify discrepancies prior to monitoring visits and data locks.
- Partnered with clinical and operational stakeholders to track site performance, monitor entry delays, and resolve data issues.
- Contributed to root-cause investigations, CAPA implementations, and continuous improvement initiatives for data quality events.
Biomedical Tendering Assistant / Technical Assistant
Safwan Trading & ELM Wataniya
02.2015 - 10.2016
- Managed contract and technical documentation databases, maintaining strict data traceability, control trackers, and compliance processes.
Clinical Trial Coordinator
Apollo Hospitals Educational & Research Foundation
04.2012 - 04.2013
- Reviewed patient clinical data—including eligibility criteria, medical history, concomitant medications, adverse events, and safety outcomes—in alignment with protocol requirements.
- Supported monitoring visits, safety reporting, and Case Report Form (CRF) source data verification (SDV) for multi-centre clinical trials.
- Monitored site data entry performance and facilitated clear communication between principal investigators, site staff, and study sponsors.
Education
MSc - Pharmacology & Drug Discovery
Coventry University
UK01-2022
BE - Biomedical Engineering
Anna University
India01-2009
Skills
- Clinical Data Quality Review
- Discrepancy Identification
- Query Management
- Patient Eligibility & Safety Data Review
- Source Data Verification (SDV)
- ALCOA Data Integrity
- GCP & Protocol Compliance
- Medidata RAVE
- INFORM
- REDCap
- Veeva Vault eTMF
- Montrium
- Clinergize
- Agatha
- DIA TMF Reference Model
Certification
- Diploma in Clinical Data Management
- Advanced Diploma in Clinical Research
- UK GDPR & EU GDPR Certified
- NHS Accredited Phlebotomy Training
Additional Details
- Visa Status: Full right to work in the UK
- Availability: Immediately available
- Travel: Open to travel to sites, if needed
- Remote Work: Equipped with a dedicated home workstation
Timeline
Study Document Associate
Allergy Therapeutics
09.2025 - 09.2026
Clinical Trial Associate
Research Organization (KC) Ltd.
12.2024 - 04.2025
Clinical Data Compliance Coordinator
Synexus Midlands (Thermo Fisher Scientific)
04.2023 - 06.2024
Biomedical Tendering Assistant / Technical Assistant
Safwan Trading & ELM Wataniya
02.2015 - 10.2016
Clinical Trial Coordinator
Apollo Hospitals Educational & Research Foundation
04.2012 - 04.2013
MSc - Pharmacology & Drug Discovery
Coventry University
BE - Biomedical Engineering
Anna University