Band
Level 6
Job Description Summary
LOCATION: Basel City, SwitzerlandROLE TYPE: Hybrid Working, #LI-Hybrid
The Study & Site Operations (SSO) Study Start-Up (SSU) Cluster Head is accountable for the governance and oversight of the study start-up team in the cluster. They are accountable for the cluster SSU strategy and prioritization in close collaboration with SSO Cluster Head Portfolio and SSO Country Heads to deliver operational excellence of the Global Drug Development (GDD) portfolio in compliance with Novartis processes, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use )ICH) / Good Clinical Practice (GCP) and regulatory requirements. The role may support larger scope projects and governance in SSU as applicable
Job Description
Collaborating with the Study & Site Operations Cluster Leadership Team to identify innovative practices to optimize cluster operations and operational excellence, especially in terms of study start-up activities to increase performance, productivity, and business impact. The SSO SSU Cluster Head defines and continuously optimizes cluster SSU strategy in close collaboration with the SSO Cluster Head and SSO Cluster Head Portfolio, whilst being accountable for timely start-up activities from country allocation until Green Light (ready-to-initiate-sites). They will also ensure close collaboration with local Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs) and Health Authorities (HA).
Major accountabilities:
Collaborates with SSO 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 Trial Master File (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, HA and Standard Operating Procedure (SOP) requirements
Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all time
Resource management and reporting of Study Start-Up Team
Manages and oversees productivity targets per defined objectives, and serves as an escalation point for Study Start-Up functions
Collaborates with SSO Cluster Head Portfolio to plan, track, and communicate future portfolio expectations.
Direct Interface with Global SSU Teams to provide feedback on future and ongoing programs and trials, plan timelines, and proactively manage issue resolution for full portfolio within the Cluster.
Key performance indicators:
Performance against study commitments at the cluster level (actual vs. planned patients), including set-up/delivery of trials per defined timelines and milestones (IRB/IEC & HA approval, Regulatory Information System (RIS), Site Initiation Visit (SIV)) and data quality requirements
Delivery of study milestones in adherence to prevailing legislation, ICH/GCP, IRB/IEC, HA and SOP requirements
Timely submission and delivery of high-quality clinical trial documentation/data
Minimum Requirements:
A university degree in scientific or health discipline required
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
Strong interpersonal, negotiation and conflict resolution skills
Communicates effectively in a local/global matrixed environment
Fluent in both written and spoken English
Benefits: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, be-cause of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Skills Desired
Clinical Research, Clinical Trials, People Management, Program Management, Regulatory Compliance, Resource Management (Organizational), Risk Management
