Job Title: Clinical Data Associate II
Company: Thermo Fisher Scientific (PPD Clinical Research Portfolio)
Work Schedule: Standard (Monday–Friday)
Work Environment: Office-based role
Travel: Occasional travel to site locations
About the Company
Thermo Fisher Scientific is a global leader in clinical research and scientific services, supporting top pharmaceutical companies and biotech organizations worldwide. Through its clinical research operations, the company enables large-scale clinical trials across 100+ countries, helping bring new therapies and medical devices to market.
Role Overview
The Clinical Data Associate II is responsible for performing advanced clinical data management and data cleaning activities. The role ensures high-quality, accurate clinical trial data in compliance with Good Clinical Practice (GCP) guidelines and organizational SOPs. The position focuses on data discrepancy resolution, query management, and clinical database review activities.
Key Responsibilities
1. Data Cleaning & Discrepancy Management
Identify, investigate, and resolve data discrepancies
Update clinical data management systems as required
Ensure accuracy and consistency of clinical trial data
2. Query Management
Generate, track, and resolve data clarification queries
Communicate with stakeholders to resolve missing or inconsistent data
Maintain documentation of query resolution activities
3. Data Review & Validation
Review data listings for accuracy and completeness
Analyze and resolve data validation reports
Ensure consistency across clinical trial datasets
4. Reporting & Documentation
Prepare project-specific status reports for CDM management and clients
Maintain documentation in accordance with SOPs and regulatory standards
5. Reconciliation Activities
Perform:
Serious Adverse Event (SAE) reconciliation
Third-party vendor data reconciliation
Ensure alignment of external and internal clinical data sources
6. System & CRF Support
Support CRF (Case Report Form) design using graphic design tools (as needed)
Work with clinical data systems such as RAVE and/or Veeva EDC
Required Qualifications
Bachelor’s degree or equivalent in a relevant field
Minimum 4+ years of experience in Clinical Data Management
Hands-on experience with:
RAVE EDC and/or Veeva EDC
Key Skills & Competencies
Clinical Data Management Skills
Strong understanding of clinical trial data processes
Knowledge of medical and clinical terminology
Understanding of Data Validation Manuals and study protocols
Technical & Analytical Skills
Strong attention to detail and numerical accuracy
Ability to work with clinical databases and interactive systems
Strong analytical and problem-solving skills
Communication & Collaboration
Strong written and verbal communication skills
Ability to interact with internal teams and clients
Strong interpersonal and customer focus skills
Work Execution Skills
Ability to work independently with moderate supervision
Strong organizational skills
Ability to handle multiple tasks and deadlines
Compliance & Professional Standards
Adherence to:
Good Clinical Practice (GCP)
SOPs / Work Process Documents (WPDs)
Ability to maintain confidentiality of clinical and client data
Good judgment in decision-making
Working Environment
Office or clinical environment
Standard corporate tools and systems used
Occasional travel to clinical sites may be required
Role Impact
Ensures accuracy and reliability of clinical trial data
Supports safety and efficacy evaluation of investigational drugs and devices
Contributes directly to global clinical research outcomes
Plays a key role in regulatory-compliant data management processes
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Remote, India | Siliguri |Illinois :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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