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WHAT - Summary & Purpose Of The Position
The Centralized Monitoring Director is a leadership role responsible for defining, implementing, and governing Centralized and risk-based monitoring (RBM) strategies across the company’s clinical development portfolio. This role ensures high-quality oversight of clinical trials by leveraging advanced analytics, Centralized data review, and innovative technologies to proactively identify and mitigate risks, safeguard patient safety, and ensure data integrity and regulatory compliance. As a sponsor-side leader, this role provides strategic direction and oversight of internal teams and external partners, ensuring alignment with global regulatory expectations and corporate quality standards.
WHAT - Main Responsibilities & Technical Competencies
Enterprise Strategy & Governance
- Define and implement the Centralized monitoring and RBM strategy across the assigned region, ensuring alignment with the global CDO strategy.
- Establish policies, SOPs, and governance frameworks aligned with global regulations.
- Ensure consistent implementation across clinical programs within the assigned region and alignment with global standards.
- Provide input into protocol and study design.
- Interacts with and influences all levels of management and cross-functional team members in Clinical Development Operations to achieve high standards in Centralized Monitoring.
- Partner with Clinical Operations, Data Management, Biostatistics, Quality, and Technology teams to drive integrated data surveillance.
Risk-Based Monitoring Leadership
- Provides strategic direction, leadership, and oversight to the assigned CM team, ensuring the successful delivery of CM activities and study deliverables across assigned projects.
- Leads the development, training, mentoring, and performance of departmental staff while fostering effective collaboration with cross-functional partners.
- Provides strategic oversight of Centralized monitoring activities to ensure quality, timely risk identification and data-driven decision making throughout study execution. Drive RBM adoption at study design stage.
- Determine and oversee Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) to enhance study success.
- Identify cross-study and portfolio-level risks.
- Monitor portfolio-level trends and recommend proactive mitigation strategies to senior leadership.
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Oversight of Clinical Programs & Service Providers
- Oversee Centralized monitoring activities performed internally and by Service Providers.
- Ensure adherence to RBM standards and KPIs.
- Review monitoring outputs and risk signals.
- Serve as escalation point for critical risks.
Advanced Analytics & Data Insights
- Lead analytics and dashboard development.
- Enable real-time data-driven decision making.
- Collaborate with data management, clinical operations and biostatistics teams.
Inspection Readiness & Compliance
- Act as accountable leader during audits and inspections.
- Ensure regulatory compliance and inspection readiness.
- Support audits and regulatory inspections.
Innovation & Digital Transformation
- Define the roadmap for future Centralized monitoring capabilities, including AI, automation and advanced analytics.
- Implement advanced technologies including AI/ML.
Team Leadership & Development
- Build, lead and develop a high-performing Centralized Monitoring team, fostering technical excellence, accountability, collaboration and continuous improvement. Recruits, hires, and trains the front-line Centralized Monitoring team, including therapeutic area training, compliance training and study management-specific knowledge as required to perform assigned tasks.
- Foster a culture of quality and innovation.
HOW - Behavioural Competencies Required
Social Agility
- Builds trusted relationships across Clinical Operations, Data Management, Biostatistics, Quality, Technology and external partners to achieve shared goals. Collaborates effectively across functions and geographies, influences without authority, and adapts communication to diverse stakeholders. Fosters an inclusive environment where different perspectives are valued and decisions are guided by what is best for patients and study outcomes.
Growing Self And Others
- Builds and develops high-performing teams through coaching, mentoring and continuous feedback. Creates a culture of accountability, collaboration and continuous learning, empowering individuals to take ownership while sharing knowledge and best practices. Encourages innovation, curiosity and the development of future talent to strengthen organizational capability.
Being Intentional
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- Provides strategic direction in a complex and evolving environment by making informed, data-driven decisions and setting clear priorities. Takes ownership of outcomes, anticipates risks, embraces change and challenges established ways of working to continuously improve Centralized monitoring capabilities and deliver innovative solutions that advance clinical development.
Making Real Impact
- Delivers measurable improvements in patient safety, data integrity, quality, compliance and operational performance through execution excellence and continuous improvement. Leverages digital technologies, advanced analytics and automation to drive innovation, while maintaining a strong focus on delivering sustainable business value and accelerating the development of medicines for patients.
HOW - Knowledge & Experience
Knowledge & Experience (essential):
- 10 + years of experience in clinical development, including significant experience in Centralized monitoring, RBQM (Risk-Based Quality Management), Data Management and/or Clinical Operations. Demonstrated experience implementing Risk-Based Quality Management (RBQM) principles in global clinical trials.
- Experience establishing or transforming Centralized monitoring capabilities.
- Experience leading cross-functional and geographically dispersed teams.
- Experience managing strategic partnerships and external service providers.
- Strong strategic thinking, influencing and change management capabilities.
- Excellent written and verbal communication and executive stakeholder management skills.
- Advanced knowledge of broad drug development process and deep expertise in Centralized monitoring.
- Leadership experience managing global teams and vendors.
- Advanced leadership skills
- Strong knowledge of Good Clinical Practice and related global regulatory and compliance requirements for clinical studies.
- Demonstrates problem solving and decision making;
- Ability to apply critical and analytical thinking
- Project management excellence in planning, prioritization and organizational skills.
- Used to managing multiple priorities in a dynamic environment. Agile mind-set
Education / Certifications (essential)
- Bachelor’s degree in Life Sciences or related field (advanced degree preferred).
Language(s) (essential)
- Fluent in English
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Skills
Centralized Monitoring
Risk-Based Quality Management
Clinical Development
Data Management
Clinical Operations
Strategic Leadership
Regulatory Compliance
Good Clinical Practice
Advanced Analytics
AI/ML
Project Management
Stakeholder Management
Change Management
Risk Mitigation
Data Integrity
Vendor Management
Location