Overview
In this leadership role you oversee Centralized Monitoring and risk-based monitoring strategies across Ipsen’s clinical portfolio. You will guide internal teams and external partners to ensure high-quality trial oversight, data integrity, and patient safety through advanced analytics and RBM. You’ll shape governance, standards, and inspection readiness while driving digital transformation. This is an opportunity to influence global Clinical Development Operations and partner with cross-functional teams to advance medicines for patients.
Responsibilities
- Define and implement Centralized Monitoring and RBM strategy aligned with global standards
- Establish policies, SOPs, and governance frameworks across regions
- Provide input into protocol and study design; interact with senior management
- Lead cross-functional collaboration with Clinical Operations, Data Management, Biostatistics, Quality, and Technology
- Direct Centralized monitoring activities for internal teams and Service Providers; ensure RBM KPIs and quality signals
- Oversee analytics, dashboards, and real-time data-driven decision making
- Ensure regulatory compliance and inspection readiness; support audits and inspections
- Define roadmap for AI, automation, and advanced analytics in Centralized Monitoring
- Build and develop a high-performing team; recruit and train staff
- Foster a culture of quality, collaboration, and continuous improvement
Key requirements
- 10+ years in clinical development with Centralized Monitoring, RBQM, Data Management or Clinical Operations
- Experience implementing RBQM principles in global trials
- Proven track record transforming Centralized Monitoring capabilities
- Experience leading cross-functional and geographically dispersed teams
- Experience managing strategic partnerships and external vendors
- Strong strategic thinking, change management, and executive communication skills
- Advanced knowledge of drug development and Centralized Monitoring; GCP and regulatory compliance
- Global leadership experience and vendor management
- Ability to manage multiple priorities in a dynamic environment; agile mindset
- Educational background in Life Sciences with advanced degree preferred
- Social agility
- Growing self and others
- Being intentional
- Centralized Monitoring
- RBQM (Risk-Based Quality Management)
- Advanced analytics and dashboards
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