Leader of Clinical Monitoring (Digital & AI Transformation Focus)
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 solutions enable more efficient clinical research, more effective healthcare delivery, and more accurate precision and predictive medicine. Our target audiences are patients, providers, principal investigators, and innovators who work in healthcare and life sciences.
Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place.
1. Responsibilities
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 maximised ROI and scale.
AI & Digital Enablement
Build and deploy an agent powered monitoring workforce to optimise monitoring
outcomes and service delivery.
Leveraging our production agents, deliver end to end monitoring services optimised 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.
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.
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.
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.
2. Experience
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.
3. Skills
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.
4. Education, Certifications, Licenses
Advanced degree in Life Sciences, Medicine, Pharmacy, or related field.
5. Travel Requirements
As required.
At Medable, we believe that our team of Medaballers is our greatest asset. That is why we are committed to your personal and professional well-being. Our rewards are more than just benefits - they demonstrate our commitment to providing an inclusive, healthy and rewarding experience for all our team members.
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 hr@medable.com.