Job Description Summary We are seeking a dynamic and experienced SSU Team Lead to join our passionate team.
This pivotal position reports directly to the SSU Country Head and is responsible to lead, mentor and provide governance to the SSU Managers team.
SSU Managers are responsible to plan and coordinate trial start-up activities for assigned trials, leading the local SSU trial teams at country level to achieve timely completion of trial start-up activities.
SSU Managers are also responsible to carrying out all regulatory procedures necessary for the implementation of a clinical trial, as well as the necessary notifications and authorization requests throughout the entire trial.
The SSU Team Lead will therefore play a critical role in setting up the right strategy within SSU Managers team, to guarantee that both, trial SSU timelines and regulatory requirements are met.
The SSU Team Lead will be key in shaping the country SSU strategy and prioritization, in close collaboration with SSU Country Head and country and SSU leadership team, to deliver operational excellence in compliance with Novartis processes, ICH/GCP and regulatory requirements.
About the Role The SSU Team Lead ensures that processes and goals are met and actively drives innovation and simplification processes while also playing a crucial people management role by mentoring and developing the SSU team, fostering a culture of excellence and accountability.
Your responsibilities include, but are not limited to:
Study Start-Up Strategy Supports 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. Supports country SSU strategy in close collaboration with SSU 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 applicable. Allocation, Initiation and Conduct of Trials Collaborates with Head Portfolio, Portfolio Team Leads and global study team (Clinical Operations Program Head, Trial Lead, SSU Lead) 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. People and Resource Management Hiring, training, development, and retention of SSU Managers. Resource management and reporting of SSU Managers. 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. Interfaces with global trial execution organization through Global SSU managers for all portfolio deliverables. Experience/Professional Requirement: Minimum 5 years' experience in clinical operations and planning. Proven 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 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. Skills Desired: Budget Management Clinical Trials Negotiation Skills People Management Process Improvement Project Planning Vendor Management Waterfall Model
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