[Hiring] Leader of Clinical Monitoring (Digital & AI Transformation Focus) @Medable

Role Description

Medable's mission is to get effective therapies to patients faster. We provide an end-to-end, agentic clinical trial platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations, and pharmaceutical sponsors to work together as a team in clinical trials.

Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers.

• Strategic Leadership & Transformation
  • 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 maximized ROI and scale.
• AI & Digital Enablement
  • Build and deploy an agent powered monitoring workforce to optimize monitoring outcomes and service delivery.
  • Leveraging our production agents, deliver end-to-end monitoring services optimized for autonomous activity with human-in-the-loop services.
  • 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.
• Operational Excellence & Productivity
  • Optimize monitoring resource allocation using data-driven approaches to deliver target margins, revenue, and SLA’s.
  • Realize enhanced CRA (Clinical Research Associate) productivity through optimized 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.
• Quality & Compliance
  • 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.
• Global Team Leadership
  • 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.
• Stakeholder Engagement
  • Serve as a key interface with executive leadership on clinical operations performance and innovation.
  • Inspire 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.

Qualifications

• 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.

Requirements

• 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.

Education, Certifications, Licenses

• Advanced degree in Life Sciences, Medicine, Pharmacy, or related field.

Travel Requirements

• As required.

Benefits

• Flexible Work
  • Remote from the start, we believe in a flexible employee experience.
• Compensation
  • Competitive base salaries.
  • Annual performance-based bonus.
  • Stock options for employees, aligning personal achievements to Medable's success.
• Health and Wellness
  • 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).
• Recognition
  • Peer-to-peer recognition program, celebrating achievements and milestones.
• Community Involvement
  • Volunteer time off to support causes you care about.

Medable is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or would like to request an accommodation due to a disability, please contact us at [email protected].