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