Clinical Data Associate II
Company: Thermo Fisher Scientific
Work Schedule: Standard (Monday–Friday)
Work Environment: Office / Clinical Environment
About the Role
Thermo Fisher Scientific is seeking a Clinical Data Associate II to support advanced clinical data management and data cleaning activities across global clinical trials.
In this role, you will ensure high-quality data processing in compliance with Good Clinical Practices (GCPs) and SOPs/Work Process Documents (WPDs). Your work will directly support the assessment of safety and efficacy for investigational products and medical devices.
The organization has supported:
Top 50 pharmaceutical companies
750+ biotech companies
2,700+ clinical trials across 100+ countries in the last 5 years
Key Responsibilities
1. Data Cleaning & Query Management
Identify, resolve, and update data discrepancies in clinical databases.
Modify and correct data in clinical data management systems as required.
Generate, track, and resolve data queries and clarifications.
2. Data Review & Validation
Review data listings for accuracy, completeness, and consistency.
Analyze and resolve:
Data validation reports
Data management reports
Ensure data quality across clinical trial datasets.
3. Reporting & Documentation
Produce project-specific status reports for:
CDM management
Clients
Maintain accurate documentation of data management activities.
4. Clinical Data Operations
Perform key data management activities such as:
Serious Adverse Event (SAE) reconciliation
Third-party vendor reconciliation
Data listing reviews
May support CRF (Case Report Form) design using designated tools.
Educational Qualifications
Bachelor’s degree or equivalent in a relevant field.
Experience Requirements
Minimum 4+ years of experience in Clinical Data Management.
Hands-on experience with:
Medidata RAVE
Veeva EDC
Required Skills & Competencies
Technical Skills
Strong understanding of:
Clinical data management systems
Data validation processes
Clinical trial protocols
Data Validation Manuals (DVMs)
Experience with EDC platforms (RAVE / Veeva).
Analytical Skills
Strong attention to detail and numerical accuracy.
Good analytical and problem-solving abilities.
Ability to review complex datasets and identify inconsistencies.
Communication Skills
Strong written and verbal communication skills.
Good command of English grammar and professional communication.
Personal & Behavioral Skills
Ability to work independently with moderate supervision.
Strong organizational and multitasking abilities.
High level of confidentiality handling sensitive clinical data.
Strong teamwork, flexibility, and adaptability.
Good judgment and decision-making skills.
Working Conditions
Office or clinical environment.
Exposure to standard office equipment.
Occasional travel:
Domestic
Site visits required
May require occasional field visits or travel.
Why Join Thermo Fisher Scientific?
At Thermo Fisher Scientific, you will be part of a global organization committed to:
Scientific excellence
Clinical research innovation
Data-driven healthcare solutions
Collaboration and professional growth
You will contribute directly to improving global patient outcomes through high-quality clinical data management.
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