Major accountabilities but not limited to:

• Support the establishment and implementation of a CM function at Novartis, including processes, tools, and governance frameworks to support RBQM.
• Manage and mentor a team of CMs, fostering professional development, ensuring alignment with CM processes, and maintaining high performance across the team.
• Partner with the CM Head to set, refine and implement the CM strategy, contributing to the continuous improvement of Risk-Based Monitoring (RBM) processes across the organization.
• Oversee the analysis and interpretation of CM dashboards and data visualization tools to identify and contextualize risk signals and ensure accurate root cause analysis and mitigation actions
• Provide strategic input during protocol development and study setup to ensure comprehensive risk identification and alignment with RBQM objectives and processes.
• Ensure appropriate trial data surveillance to deliver quality and integrity of the trials’ clinical dat
• Act as a key stakeholder in the evaluation, adoption, and improvements of the CM tools and technologies, ensuring effective integration into workflows.
• Drive innovation in the use of analytics, visualization, and data-driven techniques to enhance risk identification and monitoring capabilities.

Education & Experience:

• University degree in life science, business or operations; Advance degree preferred
• ≥ 7 years of recent pharmaceutical industry experience, with previous experience in clinical research, in a Pharmaceutical Industry or CROs. Strong clinical experience with excellent understanding of clinical trial development and risk management processes and the management of clinical trials (including trial design, protocol development, study start-up, patient recruitment and study close-out).
• Specific Central monitoring / monitoring experience (hands-on experience with Key Risk Indicators -KRIs- review, centralized monitoring and quality tolerance limits -QTLs-) are strongly preferred,
• Experience in implementing or working within Risk-Based Quality Management (RBQM) and adaptive monitoring frameworks
• ≥ 3 years of recent experience in people management and/or team leadership. Strong leadership and people management skills in global setting and proven ability to develop high performing teams and diverse profiles including manager of manager experience.
• ≥ 5 years comprehensive experience in monitoring (central, site), clinical data analytics, data management activities or equivalent.
• Knowledge of overall clinical trial ‘planning and execution process, understanding of the protocol, study associated risks and their significance, and the risk management process.
• Proven experience in developing, implementing, and maintaining quality control documentation for remote/central monitoring activities, ensuring data integrity, completeness, and accuracy.
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities, and Novartis standards.
• Advanced critical thinking and analytical skills to understand/analyze/interpret complex clinical and operational data and provide insight into risk signaling, trends, and outliers in data
• Ability to interpret study protocols, assess study-associated risks, and understand operational and quality implication.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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