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 accordance with Good Clinical Practices (GCPs) and SOPs/Work Process Documents (WPDs). Your work will help assess the safety and efficacy of investigational products and medical devices.
The organization has supported:
Top 50 pharmaceutical companies
750+ biotechnology companies
2,700+ clinical trials across 100+ countries (last 5 years)
Key Responsibilities
1. Data Cleaning & Query Management
Identify, resolve, and update data discrepancies in clinical databases.
Make necessary updates in the data management system.
Generate, track, and resolve data queries and clarifications.
2. Data Review & Validation
Review data listings for accuracy, consistency, and completeness.
Analyze and resolve:
Data validation reports
Data management reports
Ensure overall data quality across assigned studies.
3. Clinical Data Operations
Perform key data management tasks such as:
Serious Adverse Event (SAE) reconciliation
Third-party vendor reconciliation
Data listing reviews
May support CRF design using designated tools.
4. Reporting & Documentation
Prepare project-specific status reports for:
CDM management
Clients
Maintain accurate documentation of all data management activities.
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 processes
Clinical trial protocols
Data Validation Manuals (DVMs)
EDC systems (RAVE, Veeva)
Proficiency in data review and validation processes.
Analytical Skills
Strong attention to detail and numerical accuracy.
Good analytical and problem-solving abilities.
Ability to identify and resolve data inconsistencies.
Communication Skills
Strong written and verbal communication skills.
Good command of English language and grammar.
Ability to communicate with internal teams and clients.
Behavioral Skills
Ability to work independently with moderate supervision.
Strong organizational and multitasking skills.
High level of confidentiality in handling clinical data.
Flexibility and adaptability to changing priorities.
Strong teamwork and interpersonal skills.
Good judgment and decision-making ability.
Working Conditions
Office or clinical environment.
Exposure to standard office equipment.
Occasional travel:
Domestic
Site visits as required
Why Join Thermo Fisher Scientific?
At Thermo Fisher Scientific, you will be part of a global organization committed to:
Scientific innovation
High-quality clinical research
Collaboration and teamwork
Professional growth
Improving global healthcare outcomes
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