JobMesh

Head, Clinical Document Management Integrated Systems Director

Novartis · Dublin, Leinster, IE

Band Level 6 Job Description Summary This position plays a critical leadership role in a complex matrix with all parts of the R&D organisation that contribut...

Job description

Band Level 6 Job Description Summary: This position plays a critical leadership role in a complex matrix with all parts of the R&D organisation that contribute essential records for drug development and implement strategies that incorporate many systems that hold clinical trial data. The Head, Clinical Document Management Integrated Systems Director drives initiatives in the Clinical Document Management tech space for example for: the implementation and embedding of regulatory, safety and site document exchange mechanisms in a sustainable way of working and integration of these capabilities into future clinical TMF strategies; the integration of existing systems and functionalities with future direction including AI/ML, genAI and automated workflows; support Non-Interventional study information management needs; incorporating clinical information from external sources contributing to the conduct of studies (e.g. CROs, BD&L inlicensed partners) including processes and automation, integration of these into the TMF strategies. You would also be responsible for designing and developing new business processes and strategies while proactively identifying business risks and proposing and...