Medical Data Reviewer
Location: Bangalore, India
Work Arrangement: Office or Home-Based
Employment Type: Full-Time
Company: ICON
Job Requisition ID: JR157555
Position Overview
ICON is seeking a Medical Data Reviewer to support clinical data review activities for clinical trials. The role focuses on reviewing clinical and medical data, identifying data quality issues, raising and resolving queries, monitoring trends, and ensuring data integrity throughout the study lifecycle.
The Medical Data Reviewer will work closely with Clinical Scientists, Medical Directors, Data Management, Clinical Operations, CRAs, and clinical trial sites to ensure that clinical data is accurate, complete, consistent, and ready for key study milestones and regulatory activities.
Key Responsibilities
Clinical and Medical Data Review
Perform ongoing clinical and medical review of assigned patient data and study documents.
Identify data errors, inconsistencies, and issues requiring clarification from clinical trial sites.
Review key patient information, including:
Patient eligibility
Diagnosis and medical history
Prior treatments
Study drug administration
Adverse Events (AEs)
Serious Adverse Events (SAEs)
Adverse Events of Special Interest (AESIs)
Concomitant medications
Safety laboratory results
Efficacy assessments
End of Treatment (EOT)
End of Study (EOS)
Survival data
Medical coding
Escalate relevant clinical or medical issues to Clinical Scientists and/or Medical Monitors when appropriate.
Review clinical data for protocol compliance and overall data integrity.
Clinical Data Queries
Raise clinical data queries when additional information or clarification is required.
Monitor site responses and assess whether queries have been adequately addressed.
Close queries when issues are appropriately resolved.
Re-query sites when responses or data updates are incomplete or insufficient.
Ensure applicable updates are completed in the Electronic Data Capture (EDC) system.
Support query writing and provide guidance on data clarification requirements.
Data Quality and Trend Analysis
Conduct ongoing data trend analysis to identify potential data quality issues.
Perform targeted reviews of patient data to identify trends, inconsistencies, and protocol compliance concerns.
Monitor site data entry performance.
Identify root causes of recurring data issues.
Work with relevant stakeholders to implement appropriate corrective or remedial actions.
Ensure timely follow-up and resolution of data-related compliance issues.
Maintain a strong focus on audit readiness, data quality, and data integrity.
Project Management and Clinical Data Activities
Provide clinical data project management support for assigned studies.
Serve as a subject-matter expert in clinical and medical data review and cleaning.
Support data review activities before data cuts, snapshots, interim analyses, and database lock.
Contribute to data capture requirements and guidance in accordance with study protocols and reporting requirements.
Support EDC completion training when required.
Continuously identify opportunities to improve the efficiency and quality of clinical data review activities.
Clinical Data Review Meetings
The Medical Data Reviewer may participate in meetings and review activities such as:
Protocol Deviation Reviews
Data Review and Quality Team (DRQT) meetings
Statistical Review of Clinical Data (SRCD)
Safety Monitoring Team (SMT) reviews
Data review and quality meetings
Preparation of slides for top-line study results
Data Dissemination and Scientific Support
Support the preparation and review of materials for data dissemination meetings.
Participate in meetings such as:
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-making discussions
Support the review and QC of clinical data sections for abstracts, manuscripts, oral presentations, and posters.
Assist with preparation and review of materials used to support study and program decisions.
Regulatory and Study Milestone Support
Collaborate closely with Clinical Scientists, Medical Directors, Data Management, and Clinical Operations.
Support clinical data review activities before:
Data cuts
Interim analyses
DSURs
Investigator's Brochures (IBs)
Regulatory requests
Site close-outs
Final Database Lock (DBL)
Support identification of data readiness for clinical narratives used in Clinical Study Reports (CSRs).
Participate in the review and QC of patient narratives.
Contribute to patient narrative tracking and resolution activities.
Training and Cross-Functional Collaboration
Identify clinical data training needs for CRAs, clinical sites, and other relevant stakeholders.
Communicate data review requirements and recurring issues effectively.
Work collaboratively with global cross-functional teams.
Contribute to continuous improvement of clinical data review processes and standards.
Required Qualifications
Medical or advanced healthcare qualification such as:
MD
MBBS
PharmD
Nursing degree
PhD
MSc
Equivalent relevant healthcare or life sciences qualification
At least 5 years of pharmaceutical clinical or medical data review experience.
Strong experience in clinical cross-checks and clinical data review.
8+ years of experience is preferred.
Experience in solid tumor oncology is preferred.
Experience in clinical research, pharmacovigilance, medical monitoring, or a related pharmaceutical/CRO environment.
Strong understanding of clinical trial design.
Comprehensive knowledge of Good Clinical Practice (GCP).
Understanding of the overall drug development process.
Strong knowledge of safety reporting and medical terminology.
Technical Skills
Strong clinical database navigation skills.
Experience working with Electronic Data Capture (EDC) systems.
Experience reviewing clinical listings and standard data formats.
Experience with coding review.
Training or experience in clinical query writing.
Strong Microsoft Excel skills.
Project management capabilities.
Ability to analyze and interpret complex clinical data.
Key Competencies
Excellent attention to detail.
Strong analytical and problem-solving skills.
Excellent written and verbal English communication.
Strong organizational and tracking abilities.
Ability to manage multiple priorities and meet deadlines.
Strong operational skills.
Ability to work independently with minimal supervision.
Ability to collaborate effectively within global, cross-functional teams.
Strong commitment to clinical data quality and patient safety.
About ICON
ICON is a global healthcare intelligence and clinical research organization focused on accelerating the development of new medicines and treatments for patients.
The organization promotes a values-driven culture centered on integrity, collaboration, agility, and inclusion.
Employment Requirement
Employment with ICON is subject to the candidate having the legal right to work in the country where the position is based.
Rewards and Benefits
ICON provides a comprehensive rewards and benefits package designed to support employee health, well-being, professional development, and career growth.
Benefits may include:
Competitive base salary and performance-related incentives.
Health and well-being programs.
Medical, dental, and vision coverage where applicable.
Retirement and pension plans.
Life assurance and disability coverage.
Employee assistance programs and well-being resources.
Learning and development opportunities.
Structured training and career development pathways.
Benefits may vary depending on the role, location, and applicable employment policies.
Inclusion and Accessibility
ICON is committed to providing an inclusive and accessible workplace where employees feel valued, respected, and supported.
Reasonable accommodations are available during the recruitment process for candidates who require them.
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