Clinical Data Management Associate II

Clario

2d•Onsite

About The Position

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, and documentation in compliance with SOPs, regulatory requirements, and study timelines, while collaborating closely with Clinical Data Managers and cross‑functional teams.

Requirements

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

Responsibilities

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