Manager, Clinical Monitoring

About the role

For our client, we are seeking a Manager, Clinical Monitoring to join the team of a leader in the Pharmaceuticals & Biotech space. This role will oversee clinical monitoring strategy and execution across assigned studies, with a strong emphasis on risk-based oversight, site compliance, and CRA performance. The manager will partner closely with clinical operations stakeholders to ensure monitoring plans, visit oversight, and follow-up activities support high-quality trial execution. This position also plays a key leadership role in guiding regional CRAs, strengthening inspection readiness, and helping advance drug development programs. Location: Remote - US based candidates only, no visa sponsorship available.

Pay

$132,000 – $165,000 annually

Responsibilities

• Develop and implement strategy for in-house and regional monitoring on assigned studies
• Lead monitoring activities, including review of protocols and completion guidelines
• Author or review Clinical Monitoring Plans to ensure CRA compliance
• Manage CRA monitoring visit schedules to align with risk-based indicators
• Review and finalize visit reports for regional CRAs, ensuring timely follow-up
• Track metrics related to CRA performance and site status
• Support CRAs in implementing corrective actions from monitoring activities

Qualifications

• BS in biological sciences or a related discipline
• 7+ years of experience in biotechnology or pharmaceuticals; endocrine disorders preferred
• Minimum of 2 years in a supervisory role
• Strong critical thinking and problem-solving skills for site compliance issues
• Proficiency in Good Clinical Practices, ICH Guidelines, and regulatory standards
• In-depth knowledge of drug development; prior regulatory inspection experience preferred
• Excellent writing and communication skills for clinical trial documents and interpersonal interactions
• Demonstrated leadership, management skills, and risk assessment capabilities

Benefits

• Comprehensive health insurance, including medical, dental, vision, and life coverage
• 20 days of PTO with 10 paid holidays
• Discretionary annual target bonus
• 401k match
• Stock options and an Employee Stock Purchase Plan (ESPP)
• Winter company shutdown