Lead, Clinical Monitoring – Digital & AI Transformation

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🕒 May 15

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🤖 Artificial Intelligence

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Medable

WebsiteLinkedInAll Job Openings

51 - 200 employees

☁️ SaaS

💊 Pharmaceuticals

🤖 Artificial Intelligence

💰 $300k Seed Round - MedAble on 2015-03

SaaS • Pharmaceuticals • Artificial Intelligence

Medable is a SaaS company that provides a unified, cloud-agnostic decentralized clinical trial (DCT) platform used by pharmaceutical sponsors, CROs, and research sites to streamline and accelerate clinical research. Its solutions include eCOA/ePRO, eConsent, remote monitoring, connected sensors, and AI-driven tools (Agent Studio and multiple AI agents) to automate trial master file processes, site workflows, and participant data collection. Medable emphasizes rapid study build, global scalability, integrations, and patient-centered design to reduce time-to-launch and improve trial efficiency and data quality.

📋 Description

• 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

• 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

• 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