Global Clinical Operations- Study Start-Up Team Lead

The SSO Study Start-Up Team Lead is accountable for the governance and oversight of a study start-up team in a standalone country or OPC (operating country). The SSO Study Start-Up Team Lead is supporting the country/OPC SSU strategy and prioritization in close collaboration with SSU/OPC Head and Country/OPC LT to deliver operational excellence of the GDD portfolio in compliance with Novartis processes, ICH/GCP and regulatory requirements.

Key responsibilities: Study Start-Up StrategySupports Study & Site Operations Country Leadership Team to identify innovative practices to optimize country operations and operational excellence, especially in terms of study start-up activities to increase performance, productivity, and business impactSeeks and evaluates external knowledge and best practices to enhance overall operational excellence of country trial operationsSupports country SSU strategy in close collaboration with SSU/OPC Head and Portfolio Head/Portfolio Team Lead(s)Responsible for timely start-up activities from country allocation until site Green Light (ready-to-initiate-sites)Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicableAllocation, initiation and conduct of trialsCollaborates with Head Portfolio, SSO Portfolio Team Leads and global study team (Clinical Operations Program Head, Trial Lead) to ensure SSU timelines and deliverables are met according to country commitmentsAccountable for timelines, accuracy, and quality of TMF documents, including study start-up and ongoing TMF maintenance to ensure TMF inspection readinessEnsures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirementsImplements innovative and efficient processes which are in line with Novartis strategyPeople and resource managementHiring, training, development, and retention of Study Start-Up associatesResource management and reporting of Study Start-Up associatesEnsures associates have the required level of skills to successfully set-up and execute studies with high quality and according to business objectivesManages and oversees productivity targets per defined objectives, and serves as an escalation point for Study Start-Up functionsEssential requirements:A degree in scientific or health discipline requiredFluent in both written and spoken EnglishFluent in both written and spoken country languageMinimum 5 years’ experience in clinical operations and planningProven leadership capabilities and experience (with or without direct line management responsibilities).Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoringThorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/national Health Authorities regulations and Novartis standardsStrong capability in working in a global/country matrix environmentDesirable requirements:Proven successful leadership of teams (with or without direct reports), preferably with experience in working with international teamsStrong interpersonal, negotiation and conflict resolution skills Communicates effectively in a local/global matrixed environment