Related skills
ms office sharepoint edc ctms irt📋 Description
- Understand study protocols and essential documents (CMP, ICFs, eCRFs).
- Coordinate Site Selection, Initiation, and Close-Out Visits with study teams.
- Serve as primary contact for interim analyses, database locks, milestones.
- Lead the monitoring operational strategy from start-up through close-out.
- Ensure monitoring deliverables progress on time, within scope and budget.
- Maintain an inspection-ready TMF and familiarity with TMF Reference Model.
🎯 Requirements
- Bachelor’s degree in business, life sciences, or related field.
- 5-7 years in clinical research, PM, and monitoring ops; PMP preferred.
- 4+ years managing clinical projects across full trial lifecycle.
- Deep knowledge of ICH-GCP, FDA, and global regulatory standards.
- MS Office (Excel/Word/PowerPoint) and SharePoint; EDC, TMF, CTMS, IRT.
- Strong communication, leadership, and organization; global cross-functional experience a plus.
🎁 Benefits
- Global CRO with focus on quality and professional development.
- Supportive culture and opportunities for career growth.
- Equal opportunity employer.
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