Site Monitoring Lead (Sponsor-Dedicated)

About This Role

This role is for an experienced Site Monitoring Lead (SML) to join a sponsor-dedicated team, overseeing site monitoring strategy and execution for global clinical research programs. The SML will ensure clinical trial quality, subject safety, and data integrity across multiple regions, serving as a core member of the Trial Team.

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 (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
• 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
• Demonstrated Agility, Accountability, and Intrapreneurship (AAI), with a results-oriented mindset, sound judgment, and the ability to make informed decisions

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. Oversight—not execution—of site monitoring activities.

Nice to Have

• Advanced degree

Skills

* Required skills

Benefits