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Clinical Data Reviewer(Centralized Monitoring/Clinical Scientist Support)

Syneos Health
8+ years
Not Disclosed
Remote, India, India
9 May 22, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company

Syneos Health

Job Title

Clinical Data Reviewer (Centralized Monitoring / Clinical Scientist Support)

Location

  • India

  • Remote (IND-Remote)

Job ID

  • 25109128

Employment Type

  • Talent pipeline / upcoming opportunity

  • Not currently a confirmed live opening


Company Overview

Syneos Health is a global biopharmaceutical solutions organization focused on accelerating customer success through clinical development, medical affairs, and commercial solutions. The company operates across 110 countries with approximately 29,000 employees.


Role Summary

The Clinical Data Reviewer supports centralized clinical monitoring and clinical scientist activities by reviewing clinical trial data for quality, consistency, accuracy, and compliance. The role involves medical data review, query management, cross-functional collaboration, and support for audit readiness throughout the clinical trial lifecycle.


Key Responsibilities

Clinical Data Review

Data Quality & Review

  • Perform clinical data review according to Data Review Plans (DRP)

  • Identify inconsistencies, errors, and missing data

  • Issue and manage clinical data queries

Clinical/Medical Review Areas

Review patient-related clinical data including:

  • Eligibility criteria

  • Diagnosis and medical history

  • Prior treatments

  • Adverse Events (AE)

  • Serious Adverse Events (SAE)

  • AESI

  • Concomitant medications

  • Investigational Product (IP) compliance and titration

  • Safety laboratory data

  • Efficacy assessments

  • End of Treatment (EOT)

  • End of Study (EOS)

  • Survival data

  • Medical coding activities

Query Management

  • Issue clinical queries in EDC systems

  • Follow up with sites regarding responses

  • Re-query or close queries appropriately

  • Coordinate with clinical teams for resolution


Centralized Monitoring & Compliance

Data Integrity & Audit Readiness

  • Maintain strong focus on:

    • Data quality

    • Clinical compliance

    • Audit readiness

  • Support Systems Validation Compliance activities

Compliance Management

  • Ensure timely resolution of clinical data compliance issues

  • Monitor adherence to Good Clinical Practice (GCP)

Site Performance Monitoring

  • Monitor site data entry performance

  • Identify root causes of data quality issues

  • Recommend remedial actions


Cross-Functional Collaboration

Stakeholder Collaboration

Work closely with:

  • Clinical Scientists

  • Study Medical Directors

  • Data Management teams

  • Clinical Operations teams

Training & Communication

  • Communicate training needs for CRAs and sites

  • May assist in:

    • EDC training

    • Clinical review meetings

    • Data dissemination presentations

Project Support

  • Provide project status updates related to clinical data review

  • Support activities before:

    • Interim analyses

    • Data snapshots

    • DSUR submissions

    • Investigator Brochures (IB)

    • Database lock (DBL)

    • Regulatory requests


Additional Responsibilities

Data Review Tools & Systems

Use and support systems such as:

  • EDC systems

  • ARGUS

  • JReview

  • RShiny visualizations

  • Central imaging systems

  • Clinical cross-check tools

Coding & Narrative Review

  • Review MedDRA and WHO Drug Dictionary coding

  • May support QC review of patient narratives

Process Improvement

  • Identify opportunities to improve:

    • Efficiency

    • Data quality

    • Workflow consistency


Required Qualifications

Educational Background

One of the following:

  • MBBS

  • MD

  • BDS

  • BHMS

  • BAMS

  • PharmD

  • PhD

Experience

  • 8+ years of:

    • Pharmaceutical clinical data review experience

    • Medical review experience

    • Clinical cross-check experience


Required Skills & Competencies

Clinical & Regulatory Knowledge

  • Strong understanding of:

    • Good Clinical Practice (GCP)

    • Clinical trial design

    • Drug development process

Medical Coding & Query Skills

  • Experience with:

    • MedDRA coding review

    • WHO Drug Dictionary review

  • Excellent query writing skills

Technical Skills

Strong experience with:

  • MS Excel

  • PowerPoint

  • Clinical data review systems

  • Digital analytics tools

Analytical & Operational Skills

  • Strong database navigation abilities

  • Excellent organizational and tracking skills

  • Ability to meet strict timelines

  • Attention to detail

Communication & Collaboration

  • Excellent English verbal and written communication

  • Ability to work independently and collaboratively


Preferred Experience

  • Therapeutic area-specific experience may be required depending on study assignment

  • Experience in centralized monitoring and advanced clinical review analytics preferred


Work Environment

  • Remote global clinical operations environment

  • Cross-functional collaboration with sponsor and study teams

  • High focus on data integrity, compliance, and patient safety


Career Growth & Development

Syneos Health offers:

  • Career progression opportunities

  • Technical and therapeutic training

  • Global collaboration exposure

  • Supportive management and development programs

  • Inclusive “Total Self” culture


Industry Impact

Over the past 5 years, Syneos Health has contributed to:

  • 94% of FDA-approved novel drugs

  • 95% of EMA-authorized products

  • 200+ studies across:

    • 73,000 sites

    • 675,000+ trial patients