Lead, Clinical Monitoring – Digital & AI Transformation

Medable

Leader of Clinical Monitoring overseeing digital and AI transformation initiatives in clinical trials. Driving innovative clinical monitoring strategies to enhance efficiency and service delivery at Medable.

Posted 5/15/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

ATS Keywords

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Hard Skills

clinical operationsrisk-based monitoringcentralized monitoringAI technologiesdata-driven decision-makingchange managementdigital transformationGCPregulatory requirementsclinical trial processes

Soft Skills

leadershipcommunicationstakeholder managementstrategic thinkinganalytical mindsetinnovationaccountabilitycontinuous learningcollaborationflexibility

Tools & Technologies

agentic platform solutionsAI-driven toolsmonitoring workflowsKPI dashboardsquality surveillanceaudit readinessdigital literacydata interpretationclinical research softwareSOPs

Certifications & Qualifications

advanced degree in Life Sciencesadvanced degree in Medicineadvanced degree in Pharmacy

Industry Keywords

GxPclinical monitoringmonitoring modelsglobal regulatory guidelinesclinical research associatesprofitabilitymatrixed organizationsdigital adoptionclinical trialsrisk mitigation

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Define and implement a global clinical monitoring strategy fully leveraging agentic platform solutions, aligned with 1:1:1 goals and regulatory requirements
Build a global team of highly skilled CRA’s and lead the transition from traditional monitoring to agentic powered monitoring models, including the redefinition of roles, responsibilities, operating framework and accountabilities
Champion the integration of AI-driven tools and digital agents to modernize monitoring workflows
Establish a long-term roadmap for scalable, agentic clinical monitoring operations delivering maximised ROI and scale
Build and deploy an agent powered monitoring workforce to optimise monitoring outcomes and service delivery
Ensure ethical, GxP compliant, and trustworthy use of AI in clinical operations publishing evidence and key success criteria as well as iterative embedding of learnings and best practices
Optimize monitoring resource allocation using data-driven approaches to deliver target margins, revenue and SLA’s
Realise enhanced CRA (Clinical Research Associate) productivity through optimised automation and agentic workforce augmentation
Standardize processes globally while allowing flexibility for regional regulatory differences
Develop KPIs and dashboards to track efficiency, quality, and cycle times
Ensure all monitoring activities comply with GCP, GxP, global regulatory guidelines, developing and adapting operating SOPs and a quality framework
Implement AI-powered quality surveillance to proactively identify and mitigate risks
Maintain audit readiness and support regulatory inspections
Drive continuous improvement initiatives based on quality metrics and insights
Lead and develop a high-performing global team of new era clinical monitoring professionals
Build capabilities in digital literacy, data interpretation, and AI collaboration
Foster a culture of innovation, accountability, and continuous learning
Collaborate cross-functionally with Clinical Operations, Data Management, Biostatistics, and IT
Serve as a key interface with executive leadership on clinical operations performance and innovation
Inspirate and collaborate with external partners, Sponsors, CROs, and sites to scale digital adoption
Represent the organization in industry forums on AI in clinical trials
Other duties as assigned

Requirements

What you’ll need

15+ years of experience in clinical operations, including significant leadership in monitoring, or a combination of education and experience
Proven experience implementing risk-based monitoring and centralized monitoring models and change management leading to adoption and ROI
Demonstrated exposure to digital transformation or AI-driven initiatives in clinical trials
Deep understanding of GCP, regulatory requirements, and clinical trial processes
Strong knowledge of AI technologies in clinical research
Strategic thinking with the ability to translate vision into execution
Data-driven decision-making and analytical mindset
Exceptional leadership, communication, and stakeholder management skills
Business function leadership to create and execute a profitable business model with accountability for revenue and gross margin achievement
Change management expertise in global, matrixed organizations
Advanced degree in Life Sciences, Medicine, Pharmacy, or related field

Benefits

Comp & perks

Flexible Work
Competitive base salaries
Annual performance-based bonus
Stock options for employees, aligning personal achievements to Medable's success
Comprehensive medical, dental, and vision insurance coverage
Carrot Fertility Program
Health Saving Accounts (HSA) and Flexible Spending Accounts (FSA)
Wellness program (Mental, Physical and Financial)
Peer-to-peer recognition program, celebrating achievements and milestones
Volunteer time off to support causes you care about