Overview
Clinical Data Management Associate II within Clario's Medical Imaging business, reviewing, validating and managing clinical trial data generated from imaging studies across multiple therapeutic areas.
What you'll do
- Review study documentation and project requirements to assess impacts on Clinical Data Management processes, standards, and deliverables.
- Collaborate with cross-functional teams to support study setup, data collection strategies, and evolving project requirements.
- Support the implementation and execution of data management plans for assigned imaging studies.
- Define, execute, review, and maintain edit checks to identify discrepancies and ensure high-quality clinical data.
- Review clinical and imaging-related data to identify inconsistencies, trends, and data quality issues.
- Develop and maintain study data specifications, including data transfer specifications, system configuration specifications, and data validation requirements.
- Create, review, and maintain transmittal forms and study documentation while ensuring compliance with established standards.
- Collaborate with project teams to investigate and resolve data discrepancies and outstanding issues.
- Track data-related issues through resolution and ensure timely follow-up with relevant stakeholders.
- Prepare, validate, and deliver ad hoc data listings and study reports as required.
- Identify system enhancements, bugs, or process improvement opportunities and coordinate communication with appropriate Product Management teams.
- Maintain complete, accurate, and audit-ready study documentation throughout the study lifecycle.
- Communicate project status, risks, and data quality concerns to supervisors and project stakeholders.
- Contribute to departmental process improvement initiatives, SOP updates, and quality enhancement activities.
- Support compliance with company procedures, Good Clinical Practice requirements, and applicable regulatory expectations.
What you'll need
- Bachelor's degree in Computer Science, Life Sciences, Healthcare, Clinical Research, Data Science, or a related field, or equivalent professional experience.
- Minimum 3 years of experience in Clinical Data Management, clinical research, biotechnology, pharmaceutical, CRO, or related healthcare environments.
- Understanding of clinical trial processes, data review methodologies, and clinical database management principles.
- Working knowledge of relational database concepts, data validation techniques, and quality control processes.
- Familiarity with clinical trial terminology and regulated research environments.
- Proficiency with Microsoft Office applications, including Word, Excel, Access, Outlook, and PowerPoint.
- Strong analytical and problem-solving skills with the ability to identify and resolve data quality issues.
- Excellent attention to detail and commitment to data accuracy and quality.
- Strong organizational, documentation, and time-management skills.
- Excellent verbal and written communication skills with the ability to communicate effectively in English.
- Ability to work independently while collaborating effectively within cross-functional and global teams.
- Professional, proactive, and customer-focused approach with a commitment to continuous improvement.
Nice to have
- Experience developing or maintaining data specifications, edit checks, data transfer requirements, or study configuration documentation.
Details
Read the full description and apply on the company’s own careers page.