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Clin Data Assoc Ii

Thermo Fisher Scientific
Thermo Fisher Scientific
1.6-3 years
Not Disclosed
10 Dec. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Data Associate II – Remote, India

Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Clinical Data Management
Job ID: R-01338260


About the Role

Thermo Fisher Scientific’s Clinical Research Services (CRS) team drives innovation in global clinical trials, supporting over 2,700 studies across 100+ countries for leading pharmaceutical and biotechnology companies. We are seeking a Clinical Data Associate II (CDA II) to lead advanced clinical data review and management activities, ensuring data integrity, compliance, and analysis-ready datasets across assigned studies. This role is fully remote within India and offers exposure to global clinical research operations.


Key Responsibilities

  • Perform advanced data review and cleaning to ensure high-quality, compliant, and timely datasets.

  • Manage complex queries, including Serious Adverse Event (SAE) reconciliations and third-party vendor data validations.

  • Review and analyze data listings, validation outputs, and CRF design for accuracy and consistency.

  • Generate project-specific status reports for CDM management and clients.

  • Partner with cross-functional teams to resolve data issues and mitigate project risks.

  • Maintain inspection-ready documentation and comply with SOPs, GCP, and departmental procedures.

  • Contribute to process improvements, knowledge sharing, and best practices in data management.


Education & Experience Requirements

  • Bachelor’s degree in Life Sciences, Pharmacy, or related field.

  • 1.6 to 3 years of relevant experience in Clinical Data Management, clinical data review, or coding.

  • Hands-on experience with RAVE / Veeva EDC.

  • Knowledge of clinical trial terminology, Data Validation Manuals, and study protocols.


Skills & Competencies

  • Strong understanding of clinical and medical terminology.

  • High attention to detail and analytical problem-solving skills.

  • Excellent written and verbal communication skills in English.

  • Ability to work independently with moderate supervision while adhering to regulatory guidelines.

  • Strong interpersonal skills, team collaboration, and customer-focused mindset.

  • Ability to maintain confidentiality of clinical data and proprietary information.

  • Flexibility, adaptability, and good judgment in decision-making.


Career Growth & Opportunities

This position is part of a Functional Service Provider (FSP) model supporting a globally recognized biopharmaceutical sponsor. Benefits include:

  • Exposure to global clinical trials across multiple phases and therapeutic areas.

  • End-to-end involvement in study delivery, from CRF design to database close-out.

  • Hands-on experience with modern CDM tools, AI-enabled workflows, and data analysis platforms.

  • Career progression opportunities in Senior CDM, CDTL, CDM Project Management, or Data Standards/Programming roles.

  • Collaborative work with global teams, CROs, and vendors, enhancing international clinical research expertise.


Why Join Thermo Fisher Scientific

  • Global Impact: Contribute to life-changing medicines reaching patients worldwide.

  • Professional Development: Continuous learning, mentorship, and stretch assignments.

  • Innovation & Technology: Work with cutting-edge CDM tools and AI platforms.

  • Inclusive Work Culture: Thermo Fisher Scientific fosters diversity, inclusion, and equal opportunity for all employees.


About Thermo Fisher Scientific

Thermo Fisher Scientific is a global leader in serving science, with over 90,000 employees and annual revenues exceeding $44 billion. We enable customers to make the world healthier, cleaner, and safer through innovative technologies, laboratory services, and pharmaceutical solutions. Brands include Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, and Patheon.

Equal Opportunity Employer – Thermo Fisher Scientific is committed to an inclusive and diverse workplace.