Position Details
About this role
Support core lab data management and project coordination for clinical studies, ensuring data quality, regulatory binder maintenance, and IRB compliance while coordinating with sponsor, CROs, vendors, and clinical sites.
Key Responsibilities
- Lead core lab data management on studies
- Manage timelines and data quality
- Develop training materials and SOPs
- Coordinate with Sponsor, CROs, vendors, and clinical sites
- Maintain budget/finance tracker and change orders
Technical Overview
Technical scope includes core lab modalities (PSG, MWT, MSLT, PVT, EEG, ECG), data entry/QC, study database, regulatory binder, and GCP; uses MS Office and Windows.
Ideal Candidate
The ideal candidate is a senior data coordination professional with 5+ years in core lab data management, strong regulatory and SOP knowledge, and experience leading data coordinators; comfortable with IRB processes and cross-functional communication.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Less than 5 years data coordinator experience, No core lab data management experience, No familiarity with IRB or GCP
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