Medical Data Reviewer
Company: ICON
Job Requisition ID: JR157555
Employment Type: Full-time
Work Mode: Office or Home
Location: Bangalore, India
Position: Medical Data Reviewer – India, Home-Based
Posted: 14 days ago
Role Overview
The Medical Data Reviewer will perform clinical and medical data review activities to identify data inconsistencies, safety issues, protocol compliance concerns, and other issues requiring clarification from clinical trial sites.
The role works closely with Clinical Scientists, Medical Directors, Data Management, Clinical Operations, and study teams to ensure clinical data quality, integrity, and readiness for key study milestones and regulatory activities.
Key Responsibilities
Perform ongoing clinical and medical data review to identify errors and inconsistencies requiring clarification.
Review patient-level clinical data and documents, including:
Patient eligibility
Diagnosis
Medical history
Prior treatments
Study drug administration
AE/SAE/AESI
Concomitant medications
Safety laboratory data
Efficacy assessments
End of Treatment (EOT)
End of Study (EOS)
Survival data
Medical coding
Raise clinical data queries and monitor timely follow-up with clinical sites.
Review site responses and determine whether queries have been appropriately addressed.
Close queries or issue additional queries when required.
Identify clinical data training needs for CRAs and study sites.
Conduct in-stream data trend analysis to support data quality and integrity.
Perform targeted patient-data reviews and assess protocol compliance.
Support clinical data project management activities.
Serve as a subject matter expert in clinical/medical data review and cleaning.
Maintain an audit-ready approach to clinical data quality.
Monitor site data-entry performance and help identify root causes of data issues.
Support remedial actions and timely resolution of data-compliance issues.
Identify opportunities to improve data-review efficiency and quality.
Contribute to EDC completion training when required.
Clinical Data Review Meetings
The role may participate in meetings such as:
Protocol Deviation Review
Data Review and Quality Team (DRQT)
Statistical Review of Clinical Data (SRCD)
Safety Monitoring Team (SMT) Review
Data Dissemination & Study Meetings
The position may also involve preparing or reviewing materials and presenting at:
Investigator meetings
Advisory boards
Safety cohort review meetings
Independent Data Monitoring Committee (IDMC) meetings
Steering Committee meetings
Senior management meetings
Central imaging review meetings
Study/program decision forums
Scientific & Regulatory Support
Responsibilities may include:
Reviewing clinical data before data cuts and snapshots.
Supporting interim analyses.
Supporting DSUR and Investigator's Brochure activities.
Responding to regulatory data requests.
Supporting site close-outs and final database lock.
Supporting clinical narrative readiness for Clinical Study Reports (CSRs).
Reviewing and QC-ing patient narratives.
Supporting tracking of clinical narratives.
Reviewing clinical data sections of abstracts, manuscripts, oral presentations, and posters.
Cross-Functional Collaboration
The Medical Data Reviewer will collaborate closely with:
Clinical Scientists
Medical Directors
Data Management
Clinical Operations
Clinical Compliance
Systems Validation teams
CRAs
Clinical trial sites
Other study and program stakeholders
Educational Qualifications
Preferred scientific/healthcare backgrounds include:
MD
MBBS
PharmD
PhD
MSc
Nursing
Equivalent advanced healthcare or scientific qualification
The broader requirements also allow a life sciences degree with relevant clinical experience.
Experience Requirements
Minimum 5 years of pharmaceutical clinical/medical data review experience.
Clinical cross-checking experience is required.
8+ years preferred.
Experience in clinical research, pharmacovigilance, or medical monitoring.
Experience within a pharmaceutical company, CRO, or related environment.
Solid Tumor Oncology experience is preferred.
Technical Skills
Clinical/medical data review
Clinical cross-checking
Clinical database navigation
Coding review
Clinical query writing
Data cleaning
Clinical data trend analysis
Electronic Data Capture (EDC) systems
Clinical trial data listings
Standard clinical data formats
Microsoft Excel
Project management
Knowledge Requirements
Good Clinical Practice (GCP)
Clinical trial design
Drug development processes
Safety reporting
Medical terminology
Clinical data quality and integrity
Protocol compliance
Regulatory and clinical study requirements
Key Competencies
Strong analytical ability
Excellent attention to detail
Strong written and verbal English communication
Ability to manage timelines and multiple activities
Strong organisation and tracking skills
Independent working capability
Effective cross-functional collaboration
Ability to identify, investigate, and resolve data issues
Important Eligibility Point
This role is more suitable for experienced clinical data/medical review professionals than for pure ICSR pharmacovigilance profiles.
For an M.Pharm candidate, eligibility is possible based on the broader qualification wording, but the major hurdle is the requirement for ≥5 years of pharmaceutical clinical/medical data review experience with clinical cross-checking.
If your experience is primarily ICSR processing, case intake, MedDRA coding, follow-up, and PV operations, this would not be as strong a match as the ICON Pharmacovigilance Reporting Specialist or Pharmacovigilance Manager roles you shared.
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