Site Monitoring Lead

About This Role

Lead and oversee global site monitoring activities for clinical trials, ensuring effective implementation of trial-specific strategies, data integrity, and regulatory compliance. This role provides expertise to Trial Teams on monitoring methodologies and risk-based approaches, contributing to timely delivery of clinical programs.

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 throughout all trial phases
• 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 when needed
• Contribute to innovation and process improvement, including the design and implementation of new monitoring methods and digital solutions related to trial delivery
• Collaborate cross-functionally with Clinical Operations, Quality, and other global teams to ensure seamless execution and alignment on monitoring objectives

Requirements

• Demonstrated experience as a Clinical Trial Manager with accountability for end-to-end study execution
• Proven leadership of early-phase (Phase I and IIa) clinical trials
• Oversight—not execution—of site monitoring activities
• Deep expertise in clinical operations with trial-level decision-making authority
• Strong working knowledge of ICH-GCP, Good Documentation Practice, and global regulatory requirements
• Experience leading global, multi-regional trials within a matrixed, cross-functional environment
• Demonstrated ability to manage CROs and functional vendors
• Advanced project and trial management capabilities
• 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, including planning, conduct, oversight, and closeout of clinical trials. Proven leadership of early-phase (Phase I and IIa) clinical trials.

Nice to Have

• Advanced degree

Benefits