Lead, Clinical Monitoring – Digital & AI Transformation

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🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🟠 Senior

🤖 Künstliche Intelligenz

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Medable

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

☁️ SaaS

💊 Pharmazie

🤖 Künstliche Intelligenz

💰 €300.000 Seed Round - MedAble im 2015-03

SaaS • Pharmaceuticals • Artificial Intelligence

Medable ist ein SaaS-Unternehmen, das eine einheitliche, cloud-unabhängige Plattform für dezentrale klinische Studien (DCT) bereitstellt, die von Pharma-Sponsoren, CROs und Forschungsstandorten genutzt wird, um klinische Forschung effizienter zu gestalten und zu beschleunigen. Die Lösungen umfassen eCOA/ePRO, eConsent, Fernüberwachung, vernetzte Sensoren und KI-gesteuerte Werkzeuge (Agent Studio und mehrere KI-Agenten), um Prozesse der elektronischen Prüfakte, Standortabläufe und die Erfassung von Teilnehmerdaten zu automatisieren. Medable legt Wert auf schnellen Studienaufbau, globale Skalierbarkeit, Integrationen und patientenzentriertes Design, um die Zeit bis zum Start zu verkürzen und die Effizienz der Studien und die Datenqualität zu verbessern.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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