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gcp excel smartsheet edc etmf📋 Description
- Coordinate study ops across workstreams under the Study Lead.
- Manage CROs and vendors to ensure on-time, within-budget delivery.
- Oversee monitoring activities and review monitoring visit reports.
- Maintain trackers, timelines, and deliverables; escalate risks with mitigation.
- Participate in cross-functional/vendor meetings; document decisions.
- Ensure TMF is current and inspection-ready.
🎯 Requirements
- BA/BS in life sciences or related field (or equivalent).
- 5+ years in clinical operations or CRO/pharma.
- Direct site management, monitoring, or clinical ops experience.
- Hands-on eTMF, EDC, and tracking tools (Excel, Smartsheet).
- Working knowledge of ICH-GCP and FDA/EMA regulations.
- Strong organizational and cross-functional communication skills.
🎁 Benefits
- Market-leading compensation.
- 401(k) with employer match.
- 100% employer-paid medical, dental, and vision for you and dependents.
- Hybrid work model with flexible scheduling.
- Subsidized lunch and parking on in-office days.
- Flexible PTO and holidays.
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