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

Key responsibilities:

Study Start-Up Strategy

•Collaborates with 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 impact

•Seeks and evaluates external knowledge and best practices to enhance overall operational excellence of country trial operations

•Defines and continuously optimizes country SSU strategy in close collaboration with SSO Country Head and SSO Country/Cluster Head Portfolio

•Accountable for timely start-up activities from country allocation until Green Light (ready-to-initiate-sites)

•Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable

Allocation, initiation and conduct of trials

•Collaborates with SSO Country/Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments

•Accountable for timelines, accuracy, and quality of TMF documents, including study start-up and ongoing TMF maintenance to ensure TMF inspection readiness

•Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements

•Implements innovative and efficient processes which are in line with Novartis strategy

•Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times

People and resource management

•Hiring, training, development, and retention of Study Start-Up team

•Resource management and reporting of Study Start-Up Team

•Ensures associates have the required level of skills to successfully set-up and execute studies with high quality and according to business objectives

•Manages and oversees productivity targets per defined objectives, and serves as an escalation point for Study Start-Up functions

Essential requirements:

•A university degree in scientific or health discipline required

•Fluent in both written and spoken English

•Fluent in both written and spoken country language

•Minimum 8 years’ experience in clinical operations and planning

•Minimum 4 years’ experience in people management and team leadership

•Excellent understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring

•Thorough 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 standards

Desirable requirements:

•Strong capability in working in a global/country matrix environment

•Proven successful leadership of teams, preferably with experience in working with international teams

•Strong interpersonal, negotiation and conflict resolution skills

•Communicates effectively in a local/global matrixed environment

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Regulatory Compliance

Risk Management

Program Management

Clinical Research

Resource Management (Organizational)

People Management

Clinical Trials