Lead Central Monitor

Job description

The Lead Central Monitor (Lead CM) supports the Central Monitoring Head to drive excellence in clinical trial monitoring by establishing and delivering a state-of-the-art Central Monitoring (CM) capability at Novartis in Global Clinical Operations (GCO).

The Lead CM is responsible for managing a team of Central Monitors, for developing central and site monitoring strategies, ensuring that the configuration of the CM platform aligns with strategic needs, is consistent with identified indications, program, and study risks, in alignment with the IQRMP, to ensure appropriate trial data surveillance in order to deliver quality and integrity of the trials clinical data

The Lead CM will be responsible for a portfolio of programs and related trials within a Development Unit (DU). The role will be responsible for building DU knowledge in the CM team to set adapted strategies for CM. The lead CM will seat at the GCO sub-team of the respective programs.

The Lead CM will also have trial s role:

During trial start-up, this role will be involved for the protocol development process to support risk identification, risk assessment, risk oversight (Key Risks Indicators -KRIs-) in partnership with the Risk Surveillance Lead (RSL). This role may also contribute to the establishment of trial-specific KRIs, as needed. The role will have a key responsibility in connecting with the Data Analysts team, ensuring the CM platform is appropriately configured.

During trial execution, the Lead CM will also be responsible for overseeing the CMs ongoing risk review, checking of the study data, and detection of risks utilizing technology (the CM platform) in partnership with the Data Analyst (DA), to monitor data quality, patient safety, and relevant risks. The lead CM will ensure that those data are translated into signals and insights and communicated to the Clinical Trial Teams (CTTs) for review and decision making to investigate and act appropriately. This role is critical for the detection of study-related risk/issue(s) within the scope of study RBM strategy.

About the Role

CM Establishment

• Support the establishment and implementation of a CM function at Novartis, including processes, tools, and governance frameworks to support RBQM.
• Contribute to the CM resourcing strategy, including hiring, onboarding, development, and retention of CM Team.
• Contribute to the Establishment and actively monitoring of CM objectives.