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.