Job Title: Trial Master File (TMF) Oversight Manager#LI-HybridPrimary Location: Dublin, IrelandRelocation Support: This role is based in Dublin, Ireland. Novartis is unable to offer relocation support: please only apply if accessible.When you bring structure to complexity, you unlock better outcomes for patients. As a Trial Master File (TMF) Oversight Manager, you will play a critical role in ensuring the quality, integrity, and readiness of clinical trial documentation across a global portfolio. Working at the heart of clinical operations, you’ll collaborate with cross-functional teams to strengthen governance, elevate standards, and drive continuous improvement in TMF processes—helping Novartis deliver high-quality research and transform patient care worldwide.Key ResponsibilitiesProvide oversight for the assessment of quality and completeness of Trial Master Files across a global portfolioIdentify and communicate trends, risks, and gaps in documentation and implement effective remediation plansLead vendor Trial Master File oversight activities, monitor performance metrics, and optimize operating modelsAct as escalation point for Trial Master File quality issues and drive timely resolutionServe as subject matter expert on Trial Master File processes, tools, and training materialsSupport audit and inspection readiness through proactive quality reviews and preparation activitiesContribute to root cause analysis and develop corrective and preventive action plansDrive continuous improvement in document management processes to enhance Trial Master File qualityLead or support innovation initiatives to advance Trial Master File systems and assessment approachesSupport resource planning, forecasting, and prioritization of Trial Master File high-risk and critical studiesEssential RequirementsBachelor’s degree or equivalent with relevant experience in the pharmaceutical or clinical research industryMinimum of five years’ experience in clinical research and development, including clinical documentation or records managementProven ability to plan and execute cross‑functional projects in a complex, global environmentStrong influencing and presentation skills with the ability to communicate clearly at all organizational levelsExperience working in multidisciplinary teams across different cultures and geographiesStrong organizational awareness with the ability to manage multiple priorities effectivelyDemonstrated problem‑solving, negotiation, and conflict resolution skillsAbility to build and maintain trusted relationships with internal and external stakeholdersDesirable RequirementsPeople Management experience
#J-18808-Ljbffr