Clinical Data Associate II

Description
- The Clinical Data Associate will support Clinical Data Management activities for assigned studies according to protocols, industry standards/guidelines, and SOPs (title may be Clinical Data Associate II or Senior Clinical Data Associate depending on experience).

Essential Duties and Responsibilities
- Support Clinical Data Management activities for assigned studies under the Clinical Data Manager
- Review, maintain, and file study Data Management documentation
- Participate in CRF and CRF Completion Guidelines design review to align with protocol and data collection standards
- Support testing and maintenance of clinical data systems (EDC, IRT, ePRO)
- Perform data review (data checks, query review, issues tracking)
- Prepare data listings and metrics
- Assist with data transfers and reconciliation
- Collaborate with cross-functional/internal and external partners as directed
- Track activities and escalate data issues/risks/delays to the Clinical Data Manager
- Adhere to Clinical Data Management standards and regulatory/industry requirements (ICH, GxP, CDISC, 21 CFR Part 11)
- Other duties as required

Requirements
- Education/Experience: Minimum 1 year Clinical Data Management (>2 years preferred); Bachelor’s degree or higher in a medical/scientific field
- Communication skills (verbal and written)
- Preferred: Clinical data entry system design/development/maintenance; experience executing data review plans

Knowledge and Skills
- Proficient in Microsoft Office Suite, file sharing software, and online conferencing
- Strong analytical/problem-solving and attention to detail
- Strong interpersonal skills; positive, collaborative approach

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