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Clinical Data Associate Ii

Thermo Fisher Scientific
Thermo Fisher Scientific
4+ years
preferred by company
Remote, India, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment

Clinical Data Associate II

Location: Remote, India
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Job Type: Full-Time
Work Mode: Fully Remote
Industry: Clinical Research | Clinical Data Management | CRO | Life Sciences | Pharmaceutical
Department: Clinical Research Services / Clinical Data Management
Job Reference ID: R-01338260
Work Schedule: Monday to Friday

Job Overview

Thermo Fisher Scientific is hiring a Clinical Data Associate II (CDA II) for its PPD Clinical Research Services division in India. This fully remote opportunity is ideal for experienced professionals with expertise in clinical data management, data cleaning, query management, EDC systems, SAE reconciliation, clinical database review, and clinical trial data quality management.

The selected candidate will be responsible for advanced clinical data review, discrepancy management, database maintenance, data reconciliation, and delivery of analysis-ready clinical datasets while ensuring compliance with regulatory standards and global clinical data management processes.

This role is ideal for professionals seeking growth in clinical data management, CRO clinical operations, data review, and global clinical trial execution.

Job Responsibilities

Clinical Data Review & Data Cleaning

  • Perform advanced clinical data review and cleaning activities across assigned clinical studies.
  • Ensure:
    • Data integrity
    • Data consistency
    • Timely issue resolution
    • Inspection readiness
    • High-quality clinical trial data outputs

Query Management & Data Clarification

  • Generate, track, manage, and resolve clinical data queries.
  • Identify data discrepancies and inconsistencies proactively.
  • Coordinate clarification activities with relevant stakeholders.
  • Ensure timely closure of data issues.

Database Management

  • Update and maintain the clinical data management database as required.
  • Support database changes and controlled updates.
  • Contribute to clean and analysis-ready clinical datasets.

Data Validation & Listings Review

  • Review:
    • Data listings
    • Validation reports
    • Data management reports
    • Quality review outputs

Analyze findings and resolve identified issues to improve overall data quality.

SAE & Third-Party Reconciliation

Perform data reconciliation activities including:

  • Serious Adverse Event (SAE) reconciliation
  • Third-party vendor data reconciliation
  • External clinical data consistency checks

Ensure accurate and compliant safety-related clinical data handling.

CRF Design Support

  • Support CRF (Case Report Form) design implementation where required.
  • Work with graphic design / EDC configuration tools as needed.

Reporting & Stakeholder Communication

  • Prepare regular project-specific status reports for:
    • Clinical Data Management leadership
    • Project teams
    • Clients
  • Communicate project progress, risks, and issue resolution status clearly.

Cross-Functional Collaboration

Collaborate with:

  • Clinical Data Managers
  • Clinical Operations teams
  • Safety teams
  • Biostatistics teams
  • Vendors
  • Client stakeholders

Support smooth end-to-end clinical trial data execution.

Compliance & Quality Governance

Ensure adherence to:

  • ICH GCP
  • Global SOPs
  • Work Practice Documents (WPDs)
  • Client quality requirements
  • Clinical data governance standards

Educational Qualification

Candidates must have:

  • Bachelor’s Degree
    OR
  • Equivalent relevant academic qualification

Preferred backgrounds:

  • Life Sciences
  • Pharmacy
  • Biotechnology
  • Biomedical Sciences
  • Clinical Research
  • Health Sciences

Experience Requirements

  • Minimum 4+ years of clinical data management experience
  • Strong experience in clinical data review and database management
  • Freshers are not eligible

Mandatory experience:

  • RAVE EDC
    OR
  • Veeva EDC

Preferred exposure:

  • SAE reconciliation
  • Query management
  • Clinical listings review
  • Data cleaning
  • Vendor reconciliation