CDA II – Veeva
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Location: Bangalore, India | Fully Remote
Job Type: Full-Time | Remote
Work Schedule: Standard (Mon–Fri)
Experience: Typically 4+ Years (Clinical Data Management)
Qualification: Bachelor’s Degree in Life Sciences or Related Discipline
Salary Range: Not Specified
Job Overview
Thermo Fisher Scientific is seeking a Clinical Data Associate II (CDA II) with experience in Veeva EDC to support clinical trial data cleaning and data management activities.
The CDA II will be responsible for performing advanced data cleaning processes, identifying discrepancies, and ensuring data accuracy in compliance with Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs). The role involves working closely with clinical data management teams to ensure high-quality clinical trial data for safety and efficacy analysis.
This position plays a key role in maintaining data integrity, resolving data queries, and supporting efficient clinical trial data workflows.
Key Responsibilities
1. Data Cleaning & Discrepancy Management
Identify, review, and resolve data discrepancies in clinical datasets.
Update and maintain data within clinical data management systems.
Ensure accuracy and consistency of clinical trial data.
Perform ongoing data cleaning activities as per project requirements.
2. Query Management & Data Validation
Generate, track, and resolve data queries and clarifications.
Review data listings to ensure completeness and consistency.
Analyze and resolve validation reports and discrepancies.
Ensure proper documentation and closure of data queries.
3. Clinical Data Review & Reporting
Review clinical data listings for accuracy and completeness.
Produce project-specific status reports for internal teams and clients.
Support data review activities and reporting processes.
Maintain regular communication regarding data status and issues.
4. Clinical Data Management Activities
Perform key CDM activities including:
Serious Adverse Event (SAE) reconciliation
Third-party vendor data reconciliation
Data listing reviews
Support CRF (Case Report Form) design where applicable.
5. Compliance & Quality Assurance
Ensure compliance with GCP guidelines and internal SOPs/WPDs.
Maintain high standards of data quality and integrity.
Follow regulatory requirements and client expectations.
Ensure confidentiality of clinical and client data.
Required Skills
Clinical Data Management
Strong understanding of clinical trial data processes.
Experience with EDC systems, especially Veeva.
Knowledge of data cleaning, validation, and query management.
Understanding of CRF and clinical data workflows.
Analytical & Problem-Solving Skills
Strong attention to detail and numerical accuracy.
Ability to identify and resolve data inconsistencies.
Good analytical and problem-solving capabilities.
Communication & Interpersonal Skills
Good written and verbal communication skills.
Strong command of English language and grammar.
Ability to collaborate with cross-functional teams.
Strong interpersonal and customer-focused approach.
Organizational & Technical Skills
Strong organizational and time management skills.
Ability to work with moderate supervision.
Proficiency in computer-based data systems.
Ability to manage multiple tasks and priorities.
Compliance & Domain Knowledge
Knowledge of clinical trial terminology.
Understanding of project protocols and Data Validation Manuals.
Awareness of GCP guidelines and regulatory requirements.
Ability to maintain confidentiality of sensitive data.
Preferred Qualifications
Experience in pharmaceutical or CRO clinical research environment.
Hands-on experience with Veeva EDC systems.
Experience in data reconciliation and validation processes.
Familiarity with clinical trial reporting and documentation.
Key Competencies
Clinical data cleaning and discrepancy management
Query management and data validation
Clinical trial data review and reporting
Data reconciliation and quality assurance
GCP compliance and regulatory adherence
Cross-functional collaboration
Attention to detail and data accuracy
About the Company
Thermo Fisher Scientific is a global leader in scientific services and technologies, supporting research, drug development, and healthcare innovation worldwide.
Through its clinical research division, PPD Clinical Research Services, the organization provides end-to-end clinical trial services including clinical operations, data management, regulatory affairs, and medical writing.
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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Montreal |Brussels :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Auckland |New Zealand :
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Croatia |Zagreb :
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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Niš |Bohemia :
Prague |Chile :
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