Lead, Clinical Monitoring – Digital & AI Transformation

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and execute a worldwide clinical monitoring strategy that fully utilizes agentic platform solutions, in alignment with 1:1:1 objectives and regulatory standards.

• Assemble a global team of highly proficient Clinical Research Associates (CRAs) and guide the shift from conventional monitoring to agentic-enhanced monitoring models, including the redefinition of roles, responsibilities, operational frameworks, and accountabilities.

• Advocate for the incorporation of AI-driven tools and digital agents to modernize monitoring processes.

• Create a sustainable roadmap for scalable agentic clinical monitoring operations that maximize ROI and scalability.

• Establish and deploy an agent-powered monitoring workforce to optimize monitoring outcomes and service efficiency.

• Ensure the ethical, GxP-compliant, and trustworthy use of AI in clinical operations by publishing evidence and key success criteria, as well as iteratively embedding insights and best practices.

• Enhance resource allocation for monitoring through data-driven strategies to achieve target margins, revenue, and SLAs.

• Achieve improved CRA productivity through optimized automation and agentic workforce enhancement.

• Standardize global processes while allowing for flexibility to accommodate regional regulatory variations.

• Create KPIs and dashboards to monitor efficiency, quality, and cycle times.

• Ensure compliance of all monitoring activities with GCP, GxP, and global regulatory guidelines by developing and adapting operational SOPs and a quality framework.

• Implement AI-driven quality surveillance to proactively identify and mitigate risks.

• Maintain audit readiness and assist with regulatory inspections.

• Propel continuous improvement initiatives informed by quality metrics and insights.

• Lead and cultivate a high-performing global team of modern clinical monitoring professionals.

• Build competencies in digital literacy, data interpretation, and AI collaboration.

• Promote a culture of innovation, accountability, and ongoing learning.

• Collaborate across functions with Clinical Operations, Data Management, Biostatistics, and IT.

• Act as a primary liaison with executive leadership regarding clinical operations performance and innovation.

• Inspire and partner with external stakeholders, sponsors, CROs, and sites to enhance digital adoption.

• Represent the organization at industry forums focusing on AI in clinical trials.

• Perform other duties as assigned.

⛳️ Requirements

• Over 15 years of experience in clinical operations, with substantial leadership in monitoring, or a combination of education and experience.

• Demonstrated experience in implementing risk-based monitoring and centralized monitoring models, along with change management that leads to adoption and ROI.

• Proven exposure to digital transformation or AI-driven initiatives within clinical trials.

• In-depth knowledge of GCP, regulatory requirements, and clinical trial processes.

• Strong understanding of AI technologies as applied in clinical research.

• Strategic thinker with the capability to translate vision into actionable plans.

• Data-driven decision-making skills combined with an analytical mindset.

• Outstanding leadership, communication, and stakeholder management capabilities.

• Experience in business function leadership to create and implement a profitable business model with accountability for revenue and gross margin achievements.

• Expertise in change management within global, matrixed organizations.

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

🏝️ Benefits

• Flexible work arrangements.

• Competitive base salaries.

• Annual performance-based bonuses.

• Stock options for employees, aligning personal achievements with Medable's success.

• Comprehensive medical, dental, and vision insurance coverage.

• Carrot Fertility Program.

• Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA).

• Wellness program addressing mental, physical, and financial health.

• Peer-to-peer recognition program celebrating achievements and milestones.

• Volunteer time off to support causes you care about.