Lead Central Monitor

Role Overview: As the Lead Central Monitor (Lead CM) at Novartis in Global Clinical Operations (GCO), your primary role is to drive excellence in clinical trial monitoring by establishing and delivering a state-of-the-art Central Monitoring (CM) capability. You will be responsible for managing a team of Central Monitors, developing central and site monitoring strategies, and ensuring that the CM platform configuration aligns with strategic needs and identified indications. Your role is crucial in ensuring appropriate trial data surveillance to deliver quality and integrity of the trials clinical data. Key Responsibilities: - Manage and mentor a team of CMs, fostering professional development and ensuring alignment with CM processes - Support the establishment and implementation of a CM function at Novartis, including processes, tools, and governance frameworks - Contribute to the CM resourcing strategy, including hiring, onboarding, development, and retention of CM 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 - Oversee the analysis and interpretation of CM dashboards and data visualization tools to identify and contextualize risk signals - Provide strategic input during protocol development and study setup to ensure comprehensive risk identification and alignment with RBQM objectives - Ensure appropriate trial data surveillance to deliver quality and integrity of the trials clinical data - Monitor and report on the effectiveness of CM activities, identifying opportunities for process improvements - Act as a key stakeholder in the evaluation, adoption, and improvements of the CM tools and technologies Qualifications Required: - Bachelor's degree in a relevant field - Experience in clinical trial monitoring and risk-based monitoring processes - Strong leadership skills with the ability to mentor and manage a team - Excellent communication and coordination abilities with cross-functional study teams - Knowledge of regulatory standards and compliance requirements in clinical trials (Note: Omitted additional details about Novartis and benefits and rewards as it was not included in the provided job description),