Job Title
Clinical Data Associate II (CDA II)
Work Schedule
Standard (Monday–Friday)
Work Mode
Office-Based
Company
Thermo Fisher Scientific
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in serving science with a mission to enable customers to make the world healthier, cleaner, and safer. Through its clinical research and laboratory services, including the PPD portfolio, the company supports global clinical trials across 100+ countries and partners with top pharmaceutical and biotech organizations worldwide.
For more information, visit: Thermo Fisher Scientific
Job Summary
We are seeking an experienced Clinical Data Associate II to support and lead advanced clinical data management activities across global clinical studies. The role focuses on ensuring data integrity, quality, timeliness, and inspection readiness while working in compliance with GCP guidelines, SOPs, and client requirements.
The ideal candidate will have strong experience in clinical data review, query management, SAE reconciliation, and EDC systems, with the ability to collaborate across cross-functional teams in a global clinical trial environment.
Key Responsibilities
Identify, review, and resolve clinical data discrepancies to ensure high data quality.
Generate, track, and manage data queries and clarifications with study sites and stakeholders.
Perform Serious Adverse Event (SAE) and third-party vendor data reconciliation.
Review clinical data listings for accuracy, completeness, and consistency.
Analyze and resolve data validation reports and other data management outputs.
Support CRF design and implementation using approved electronic data capture (EDC) tools.
Maintain and update clinical databases as required.
Prepare regular study status reports for internal teams and sponsors.
Ensure compliance with GCP, global SOPs, and study-specific data management plans.
Collaborate with cross-functional teams including clinical operations, biostatistics, and pharmacovigilance.
Required Qualifications
Bachelor’s degree or equivalent in a relevant discipline.
Minimum 4 years of experience in Clinical Data Management.
Hands-on experience with EDC systems such as RAVE / Medidata Rave or Veeva EDC.
Required Skills & Competencies
Strong knowledge of clinical trial data management processes and terminology.
Good understanding of medical/clinical research terminology.
Excellent attention to detail and numerical accuracy.
Strong analytical and problem-solving skills.
Ability to work independently with moderate supervision.
Strong written and verbal communication skills in English.
High level of confidentiality and data integrity awareness.
Strong organizational and multitasking abilities.
Ability to collaborate effectively in global and cross-functional teams.
Sound judgment and decision-making capability.
Working Environment
Office-based work environment with standard office equipment.
Occasional travel to clinical sites may be required.
Career Growth Opportunity
This role is part of a global Functional Service Provider (FSP) model supporting a leading biopharmaceutical organization known for innovation in specialty medicines and vaccines. The role offers strong career development opportunities in Clinical Data Management, Data Standards, and Clinical Programming, along with exposure to global studies and advanced clinical technologies including AI-driven workflows.
Why Join Us
Work on global clinical trials across multiple therapeutic areas.
Gain end-to-end exposure to clinical study data lifecycle.
Develop expertise in modern clinical data management systems and processes.
Collaborate with global experts in a high-impact scientific environment.
Contribute to the development of life-changing medicines worldwide.
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Ranchi |Sikkim :
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Remote, India | Siliguri |Illinois :
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Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
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Kyiv |Lima Region :
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Niš |Bohemia :
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