Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization

📋 Description Lead clinical monitoring activities for Phase 1–3 trials globally and domestically. Develop and implement monitoring strategies, including risk-based and centralized monitoring. Oversee CROs, CRAs, and external vendors to meet quality, timelines, and budgets. Review monitoring plans, site management, trip reports, metrics, and deliverables for compliance Establish vendor governance and address study execution challenges proactively. Collaborate with Clinical Development, Data Management, Regulatory Affairs, and Quality teams to 🎯 Requirements Bachelor’s degree in life sciences or related field; advanced degree preferred. 6–8+ years in clinical operations in biotech/pharma/CRO. Extensive experience in clinical monitoring of interventional trials. Strong knowledge of ICH-GCP, FDA, EMA regulations. Proven CRO/vendor management and partnerships experience. Experience with monitoring strategies, risk-based models, and oversight frameworks. 🎁 Benefits Competitive base salary and equity with bonus opportunities. Comprehensive benefits and remote or hybrid work options by location. Supportive, inclusive culture with growth opportunities. Opportunity to contribute to meaningful therapies for patients.