SSO Study Start-Up Team Lead

Lead the SSO Study Start-Up Team at Novartis

Summary

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). This role supports 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.

About the Role

Hybrid work model

Study Start-Up Strategy

• Supports 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.
• Supports 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 applicable.

Allocation, Initiation and Conduct of Trials

• Collaborates 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 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 Study Start-Up associates.
• Resource management and reporting of Study Start-Up associates.
• 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.

Key Performance Indicators

• Performance against study commitments at the country level (actual vs. planned patients), including set-up/delivery of trials per defined timelines and milestones (IRB/IEC & HA approval, RIS, SIV) and data quality requirements.
• Delivery of study milestones in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.
• Timely submission and delivery of high-quality clinical trial documentation/data.

Experience/Professional Requirements

• 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.

Competencies

• Strong capability in working in a global/country matrix environment.
• Proven successful leadership of teams (with or without direct reports), preferably with experience in working with international teams.

Skills & Knowledge

• Strong interpersonal, negotiation and conflict resolution skills.
• Communicates effectively in a local/global matrix environment.