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

Bachelor’s degree in Life Sciences or a related discipline; advanced degree preferred
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, including operational strategy, risk management, and execution for complex, early-stage patient populations (not limited to first-in-human studies)
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, with the ability to apply these principles at the study oversight level across FDA, EMA, and PMDA-regulated trials
Experience leading global, multi-regional trials within a matrixed, cross-functional environment, partnering closely with Clinical Operations, Data Management, Safety, Regulatory, Biometrics, and external vendors
Demonstrated ability to manage CROs and functional vendors, including monitoring, central labs, imaging, and other service providers, ensuring delivery against timelines, quality, and study objectives
Advanced project and trial management capabilities, including ownership of study timelines, milestone delivery, operational risk identification, and resolution across competing priorities
Excellent communication and stakeholder management skills, with the ability to lead and influence CRAs, vendors, and cross-functional teams in a global, matrixed structure
Demonstrated Agility, Accountability, and Intrapreneurship (AAI), with a results-oriented mindset, sound judgment, and the ability to make informed decisions in a fast-moving early-phase environment.

Benefits

Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO) and sick time

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial managementrisk managementprotocol implementationdeviation managementinspection readinessproject managementdata integrityregulatory compliancemonitoring methodologiesdigital solutions

Soft Skills

leadershipcommunicationstakeholder managementcollaborationproblem-solvingagilityaccountabilityintrapreneurshipinfluenceresults-oriented mindset