Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization

New

Based in the United StatesFull-TimeManager

Salary not disclosed

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Job Details

Experience: 6–8+ years

Requirements

6–8+ years of clinical operations experience with significant exposure to clinical monitoring oversight in interventional trials
Strong expertise in ICH-GCP, FDA, EMA, and global clinical trial regulations
Proven experience managing CROs, CRAs, and external clinical vendors
Demonstrated ability to design or improve monitoring strategies, processes, or operational frameworks
Experience with risk-based monitoring and inspection readiness activities
Strong cross-functional collaboration skills across clinical, regulatory, and data functions
Excellent communication, problem-solving, and organizational abilities
Ability to thrive in ambiguity and contribute to a scaling biotech environment

Responsibilities

Define and implement monitoring strategies, including risk-based and centralized monitoring approaches
Oversee CRO/vendor performance through KPIs, metrics, audits, and governance reviews
Review monitoring plans, trip reports, and study deliverables to ensure quality and compliance with regulatory standards
Support inspection readiness activities and contribute to regulatory inspections and audits
Develop and optimize SOPs, templates, and operational workflows to improve scalability and efficiency
Drive cross-functional collaboration with clinical, regulatory, data, and quality teams to ensure study alignment
Identify operational risks, escalate issues, and implement corrective and preventive actions
Mentor or manage clinical operations staff as the organization grows

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