Medical Scientist / Sr. Medical Scientist
Company: Syneos Health
Job Title: Medical Scientist / Sr. Medical Scientist
Job ID: 25109128
Location: Hyderabad / Bangalore, India
Department: Clinical Development / Medical Review
Experience Required: 8+ Years
Employment Type: Full-Time
Role Overview
The Medical Scientist / Sr. Medical Scientist is responsible for clinical and medical data review activities throughout the clinical trial lifecycle. The role focuses on ensuring data quality, patient safety, protocol compliance, and regulatory readiness by performing comprehensive clinical data review, query management, and cross-functional collaboration with Clinical Scientists, Medical Directors, Data Management, and Clinical Operations teams.
This position acts as a subject matter expert in medical data review, supporting study conduct, interim analyses, database lock activities, regulatory submissions, and safety reporting.
Key Responsibilities
Clinical Data Review
Perform ongoing medical and clinical review of patient data within clinical studies.
Identify inconsistencies, protocol deviations, and data quality issues.
Review and validate:
Patient eligibility criteria
Medical history
Prior treatments
Concomitant medications
Study drug administration
Dosing compliance
Safety laboratory results
Adverse Events (AEs)
Serious Adverse Events (SAEs)
Adverse Events of Special Interest (AESIs)
End of Treatment (EOT)
End of Study (EOS)
Survival follow-up data
Query Management
Generate clinical data queries based on Data Review Plans (DRPs).
Track, review, and close queries in EDC systems.
Re-query sites when responses are incomplete or inaccurate.
Ensure timely resolution of all clinical data discrepancies.
Safety & Medical Monitoring Support
Review clinical safety information for accuracy and completeness.
Escalate important medical findings to:
Clinical Scientists
Study Medical Directors
Sponsor Teams
Support data reviews prior to:
Interim Analyses
Database Locks (DBL)
DSUR Preparation
Investigator Brochures (IBs)
Regulatory Submissions
Coding Review
Review medical coding quality using:
MedDRA
WHO Drug Dictionary
Verify consistency and accuracy of coding practices.
Data Quality & Compliance
Ensure audit-ready clinical data.
Support Clinical Compliance and Systems Validation requirements.
Monitor site performance and identify root causes of data quality issues.
Recommend corrective and preventive actions.
Cross-Functional Collaboration
Work closely with:
Clinical Scientists
Study Medical Directors
Data Management Teams
Clinical Operations Teams
Sponsors
Participate in clinical data review meetings.
Support preparation of meeting materials and presentations.
Training & Process Improvement
Identify site and CRA training needs.
Support EDC and clinical data review training initiatives.
Drive process improvements to enhance data quality and operational efficiency.
Additional Responsibilities
Review patient narratives for quality and consistency.
Contribute to clinical data dissemination activities.
Support study closeout and regulatory inspection readiness.
Required Qualifications
Educational Background
One of the following qualifications is required:
MBBS
MD
BDS
BHMS
BAMS
PharmD
PhD (Life Sciences/Medical Sciences)
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