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Study Start-up Country Head

2 months ago

West London, United Kingdom Novartis Argentina Full time

Job ID- 361931BR- Feb 21, 2023- United Kingdom**Job Description**:

- 100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine - imagine the impact you could have as [Role] #GCO
- 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.
- Your responsibilities include, but are not limited to:

- 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

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

People and resource management- Hiring, training, development, and retention of Study Start-Up team
- Resource management and reporting of Study Start-Up Team

What you’ll bring to the role:

- Required Experience & Qualifications:
- Collaborates with SSO Country/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 Country/Cluster.
- 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

**Diversity & Inclusion / EEO**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum Requirements**:

- A university degree in scientific or health discipline required
- 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
- 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

GCO
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Im

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