Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization
$161,000–$208,000 year
Remote · United States or Menlo Park, California, United States
Job Summary
Lead and execute clinical monitoring strategy and optimization for Phase 1–3 trials, overseeing CROs/CRAs and external vendors; ensure high-quality trial execution in compliance with ICH-GCP and regulatory requirements; develop and refine Monitoring Plans, Risk Management Plans, Study Oversight Plans, and SOPs; implement risk-based and centralized monitoring, drive process improvements, and mentor junior clinical operations staff while coordinating cross-functionally and handling significant travel (60-80%).
Required Qualifications
- Bachelor’s degree in life sciences, nursing, or related discipline
- 6-8+ years of clinical operations experience within biotech, pharmaceutical, or CRO environments
- Significant experience overseeing clinical monitoring activities in interventional clinical trials
- Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements
- Experience managing CROs and external vendors
- Demonstrated ability to work effectively in a small, fast-moving biotech environment
- Excellent communication, organizational, and problem-solving skills
- Extensive domestic and international travel as needed (approximately 60-80%)
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