Clinical Data Associate II (CDA II) – Fully Remote, India
Job ID: R-01338260
Employment Type: Full-Time
Work Mode: Fully Remote
Category: Clinical Research / Clinical Data Management
Location: India (Remote)
Work Schedule: Monday to Friday
Job Overview
Thermo Fisher Scientific is hiring a Clinical Data Associate II (CDA II) to support global clinical trials as part of the PPD® Clinical Research Services portfolio. This role is designed for experienced clinical data professionals who can independently manage complex data review, reconciliation, and validation activities while ensuring data integrity, regulatory compliance, and inspection readiness.
As a CDA II, you will play a key role in delivering high-quality, analysis-ready clinical datasets that support accurate evaluation of safety and efficacy across international clinical studies.
Role & Responsibilities
The Clinical Data Associate II is responsible for advanced clinical data management activities conducted in accordance with ICH-GCP, study protocols, and global SOPs/WPDs.
Key Responsibilities Include:
Identify, review, resolve, and document complex data discrepancies in clinical databases
Generate, track, and resolve data queries and data clarification forms (DCFs)
Perform and support CRF design and updates using approved graphic design tools
Review data listings to ensure accuracy, completeness, and consistency
Analyze and resolve data validation checks and data management reports
Perform Serious Adverse Event (SAE) and third-party vendor data reconciliations
Produce study- and project-level status reports for Clinical Data Management leadership and clients
Collaborate with cross-functional teams to proactively identify and mitigate data-related risks
Ensure high-quality, inspection-ready datasets throughout the study lifecycle
Education & Experience Requirements
Bachelor’s degree or equivalent in Life Sciences, Pharmacy, Biotechnology, or a related discipline
1.6 to 3 years of hands-on experience in clinical data management or clinical research
Proven working experience with RAVE and/or Veeva EDC systems
Required Knowledge, Skills & Competencies
Strong understanding of clinical trial data management processes and medical terminology
Ability to work in a highly organized manner while adhering to global regulatory standards and SOPs
High attention to detail with strong numerical, analytical, and problem-solving skills
Proficiency in interactive computer programs and clinical databases
Excellent written and verbal communication skills with strong command of English
Ability to work effectively with moderate supervision
Strong customer focus and interpersonal skills
Proven ability to maintain confidentiality of clinical and proprietary data
Flexibility to work independently or collaboratively in a team environment
Sound judgment and decision-making capabilities
Working knowledge of study protocols and Data Validation Manuals
Working Conditions
Remote, office-based work environment
Occasional travel to clinical sites may be required based on project needs
Career Growth & Development
This role supports a Functional Service Provider (FSP) engagement for a globally recognized biopharmaceutical sponsor known for leadership in specialty medicines, vaccines, and scientific innovation.
As a dedicated FSP team member, you will collaborate with global data science and clinical teams, contribute to high-visibility initiatives, and operate within a mature delivery model focused on quality and long-term partnership.
Career progression opportunities include advancement to Senior Clinical Data Manager, Clinical Data Team Lead (CDTL), Clinical Data Management Project Manager, or transitions into Data Standards, Programming, or Advanced Analytics, based on performance and business needs.
Why Join Thermo Fisher Scientific
Work on international clinical trials across multiple therapeutic areas and phases
Gain hands-on experience with modern CDM tools, EDC platforms, and AI-enabled workflows
Participate in end-to-end study delivery from setup through close-out
Strengthen global project management, data analysis, and risk management skills
Be part of a mission-driven organization bringing life-changing medicines to patients worldwide
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is a global leader in serving science, with annual revenue exceeding $44 billion. With more than 90,000 colleagues worldwide, the company supports customers across life sciences research, clinical development, diagnostics, and pharmaceutical manufacturing through industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, and Patheon.
Thermo Fisher Scientific is an Equal Employment Opportunity Employer and is committed to diversity, equity, and inclusion.
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