Job Description
Role Description
- The Clinical Data Management Associate II supports the execution of clinical trials by performing day‑to‑day data management activities to ensure accurate, complete, and high‑quality clinical data. This role contributes to:
- Database build
- Data cleaning
- Query management
- Documentation in compliance with SOPs, regulatory requirements, and study timelines
Collaboration with Clinical Data Managers and cross‑functional teams is essential.
- Qualifications
- Bachelor’s degree in computer science, Life Sciences, or a related field, or equivalent practical experience
- At least 1 year of experience in a comparable role within the pharmaceutical, biotechnology, or CRO industry
- Working knowledge of relational database structures and data validation principles
- Experience using office productivity tools such as Microsoft Word, Excel, and Access
- Understanding of clinical trial terminology and regulated environments
- Demonstrated problem‑solving and analytical skills
- Ability to work independently and collaboratively in a team environment
- Strong attention to detail and organizational skills
- Effective written and verbal communication skills
- Ability to adapt to changing priorities while maintaining a professional and positive approach
- Requirements
- Review and evaluate clinical trial data to ensure accuracy, consistency, and compliance with study requirements
- Review project documentation and requirements for new studies and anticipate impacts to Data Management (DM) standards and processes
- Collaborate with cross‑functional project teams to stay informed of changes affecting data collection, data cleaning, and data transfers
- Define, execute, and review edit checks and resolve discrepant data
- Maintain organized, complete, and up‑to‑date study documentation
- Create or review Transmittal Forms to ensure consistency with established standards
- Develop study data specifications, including data transfer specifications, system configuration specifications, and data validation rules
- Identify data errors and inconsistencies and work with project teams to drive resolution
- Track outstanding data issues and follow through to resolution
- Prepare and validate ad hoc data listings as required
- Ensure system defects and enhancement needs are communicated to the appropriate Product Manager and that interim solutions are approved
- Provide regular project status updates to the supervisor
- Benefits
- Competitive compensation
- Comprehensive health, dental, and vision coverage
- Retirement savings plan with company contribution
- Paid time off and company holidays
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