Site Monitoring Lead

About This Role

Lead and oversee site monitoring activities for global clinical trials, ensuring compliance, subject safety, and data integrity. Provide expertise in monitoring methodologies and risk-based approaches while supporting inspection readiness.

Responsibilities

• Lead and oversee site monitoring activities across assigned global clinical trials, ensuring effective implementation of trial-specific monitoring strategies
• Consult and provide expertise to Trial Teams on monitoring methodologies, risk-based approaches, and oversight activities
• Ensure trial participant safety, data integrity, and regulatory compliance in accordance with study protocols, ICH-GCP, and applicable global regulations
• Manage trial-level planning, implementation, issue management, and risk mitigation related to site monitoring activities
• Support inspection readiness at all times by maintaining robust oversight, documentation, and communication processes
• Represent the function in meetings with investigational sites, vendors, and internal/external stakeholders, including regulatory agencies or inspectors
• Contribute to innovation and process improvement, including the design and implementation of new monitoring methods and digital solutions
• Collaborate cross-functionally with Clinical Operations, Quality, and other global teams to ensure seamless execution and alignment on monitoring objectives

Requirements

• Bachelor’s degree in Life Sciences or a related discipline
• Demonstrated experience as a Clinical Trial Manager (or equivalent trial-level role) with accountability for end-to-end study execution
• Proven leadership of early-phase (Phase I and IIa) clinical trials, including operational strategy, risk management, and execution for complex, early-stage patient populations
• Oversight—not execution—of site monitoring activities, including management and performance oversight of CRAs and/or CRO partners, issue escalation, and proactive risk mitigation
• Deep expertise in clinical operations with trial-level decision-making authority, including protocol implementation, deviation management, inspection readiness, and resolution of operational challenges
• Strong working knowledge of ICH-GCP, Good Documentation Practice, and global regulatory requirements (FDA, EMA, and PMDA)
• Experience leading global, multi-regional trials within a matrixed, cross-functional environment
• Demonstrated ability to manage CROs and functional vendors (monitoring, central labs, imaging, and other service providers)
• Advanced project and trial management capabilities, including ownership of study timelines, milestone delivery, operational risk identification, and resolution
• Excellent communication and stakeholder management skills

Qualifications

• Bachelor’s degree in Life Sciences or a related discipline
• Demonstrated experience as a Clinical Trial Manager (or equivalent trial-level role) with accountability for end-to-end study execution. Proven leadership of early-phase (Phase I and IIa) clinical trials.

Nice to Have

• Advanced degree

Benefits