Job Description 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). 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
Job Description
#LI-Hybrid
Location: Amsterdam, Netherlands
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
1. 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
2. Delivery of study milestones in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
3. Timely submission and delivery of high-quality clinical trial documentation/data
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
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Model