Clinical Data Associate II (Veeva)
Company: Thermo Fisher Scientific
Location: Bangalore (Fully Remote)
Job Type: Full-Time
Category: Clinical Research / Clinical Data Management
Work Schedule: Monday to Friday
Job Overview
Thermo Fisher Scientific is seeking a Clinical Data Associate II (Veeva) to support global clinical trial data management activities. This role is responsible for performing advanced data cleaning processes, ensuring data accuracy, and maintaining compliance with Good Clinical Practices (GCP), regulatory standards, and global standard operating procedures.
The position plays a critical role in evaluating the safety and efficacy of investigational products and medical devices by ensuring high-quality clinical trial data. The successful candidate will collaborate with cross-functional teams and contribute to operational excellence in global clinical research programs.
Key Responsibilities
Clinical Data Management Operations
Identify, review, and resolve data discrepancies in clinical databases.
Generate, track, and manage data queries and clarifications.
Update and maintain clinical data management systems as required.
Implement Case Report Form (CRF) design using designated tools when applicable.
Data Review and Validation
Review data listings to ensure accuracy, consistency, and completeness.
Analyze and resolve data validation issues and data management reports.
Perform data cleaning activities in compliance with GCP and standard operating procedures.
Support reconciliation activities including Serious Adverse Event and third-party vendor data reconciliation.
Reporting and Documentation
Produce project-specific status reports for clinical data management teams and clients.
Maintain documentation related to data review, validation, and query resolution processes.
Ensure confidentiality and integrity of clinical and proprietary data.
Compliance and Quality Assurance
Ensure adherence to regulatory requirements, clinical protocols, and data validation standards.
Support quality control processes to maintain high standards of clinical data accuracy.
Demonstrate understanding of project protocols and Data Validation Manuals.
Education Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related discipline preferred.
Equivalent combination of education and relevant experience may be considered.
Experience Required
Minimum 4+ years of experience in clinical data management or a related role.
Hands-on experience with Veeva Electronic Data Capture (Veeva EDC) systems.
Experience working in pharmaceutical, biotechnology, or contract research organization environments preferred.
Required Skills and Competencies
Strong knowledge of clinical data management processes and regulatory requirements.
Understanding of medical and clinical trial terminology.
Excellent attention to detail and strong numerical skills.
Strong analytical and problem-solving abilities.
Effective written and verbal communication skills with strong English proficiency.
Ability to work independently and collaboratively in a team environment.
Strong organizational and time management skills.
Ability to maintain confidentiality of clinical and proprietary information.
Flexibility and adaptability in a fast-paced research environment.
Work Environment
Office or remote work environment supporting global clinical trial operations.
Occasional travel to site locations may be required based on project needs.
Career Growth and Benefits
Opportunity to work on global clinical trials across multiple therapeutic areas.
Exposure to advanced clinical data management technologies and processes.
Professional development opportunities within a global clinical research organization.
Collaborative work environment focused on innovation and scientific excellence.
Competitive compensation and comprehensive employee benefits.
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