388532BR
Apr 19, 2024
United Kingdom
About the Role
Role location - homebased
The Senior Study Leader is responsible for the execution and delivery of the Global Clinical Operations (GCO), clinical studies in accordance with the Operational Execution Plan (OEP) and clinical study protocol.
You will lead the cross-functional Clinical Trial Team (CTT) and guide the planning and management of assigned clinical study/studies end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT) and GCO objectives.
Your responsibilities:
Your responsibilities include, but are not limited to:
• Lead the CTT delivery of multiple medium to complex global studies and promote learning, sharing, consistent performance, and operational excellence through an agile mindset, agile principles, and an agile team of teams model
• Guides planning and decisions at the study level and delivers assigned clinical study / studies per the Operational Execution Plan (OEP) and clinical study protocol
• In collaboration with regulatory writing and clinical development, promote operational excellence in the development of global clinical study protocol(s), by translating the approved study concept sheet(s) into efficient, high quality, executable clinical protocols, and study-related documents
• Fosters an agile culture within assigned studies to achieve sprint goals and cycles, maximising collaboration and minimising dependencies to achieve long term business impact
• Responsible for developing clinical study timelines and overseeing assigned study budgets
• Oversees study recruitment and responsible for activating mitigation strategies in collaboration with the Study & Site Operations (SSO) Clinical Project Manager Country representatives
• Proactive risk management and inspection readiness
• Promotes operational excellence and contributes to the development of Clinical Study Reports, reporting of clinical trial results, and internal/external publications, when appropriate
The Senior Study Leader is responsible for the execution and delivery of the Global Clinical Operations (GCO), clinical studies in accordance with the Operational Execution Plan (OEP) and clinical study protocol.
You will lead the cross-functional Clinical Trial Team (CTT) and guide the planning and management of assigned clinical study/studies end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT) and GCO objectives.
Your responsibilities:
Your responsibilities include, but are not limited to:
• Lead the CTT delivery of multiple medium to complex global studies and promote learning, sharing, consistent performance, and operational excellence through an agile mindset, agile principles, and an agile team of teams model
• Guides planning and decisions at the study level and delivers assigned clinical study / studies per the Operational Execution Plan (OEP) and clinical study protocol
• In collaboration with regulatory writing and clinical development, promote operational excellence in the development of global clinical study protocol(s), by translating the approved study concept sheet(s) into efficient, high quality, executable clinical protocols, and study-related documents
• Fosters an agile culture within assigned studies to achieve sprint goals and cycles, maximising collaboration and minimising dependencies to achieve long term business impact
• Responsible for developing clinical study timelines and overseeing assigned study budgets
• Oversees study recruitment and responsible for activating mitigation strategies in collaboration with the Study & Site Operations (SSO) Clinical Project Manager Country representatives
• Proactive risk management and inspection readiness
• Promotes operational excellence and contributes to the development of Clinical Study Reports, reporting of clinical trial results, and internal/external publications, when appropriate
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
.What you’ll bring to the role:
• Advanced or Bachelor’s degree in life sciences/healthcare or clinically relevant degree (or equivalent)
• Experience in Clinical Research or Drug Development in any Phase.
• Significant recent experience in various aspects of clinical trial activity in a global/matrix environment in pharmaceutical industry or a Contract Research Organization Including expert knowledge of international standards (ICH-GCP), health authorities (FDA/EMA)
• Experience of leading and/or working with a global team in a matrix environment, including the management of virtual teams and strong experience leading teams and building capabilities
• Experience in developing effective working relationships with internal and external stakeholders
• Strong negotiation and conflict resolution skills and enterprise mindset, demonstrated by ability to drive for aligned solutions for SSO and GCO
• Strong project management skills and demonstrated ability to meet timelines
• Proven track record in trial operations process improvement(s)
You’ll receive:
Competitive salary, Annual bonus, Strong Work/Life Balance, flexible working, Top UK Employer, Pension scheme, Share scheme, Paid holidays, Comprehensive Medical Insurance, Subsidised Canteen, Employee Recognition Scheme, Sports & Social Club, Learning and development opportunities.
Why consider Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
https://www.novartis.com/about/strategy/people-and-culture Imagine what you could do at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
We are Novartis. Join us and help reimagine medicine.
• Advanced or Bachelor’s degree in life sciences/healthcare or clinically relevant degree (or equivalent)
• Experience in Clinical Research or Drug Development in any Phase.
• Significant recent experience in various aspects of clinical trial activity in a global/matrix environment in pharmaceutical industry or a Contract Research Organization Including expert knowledge of international standards (ICH-GCP), health authorities (FDA/EMA)
• Experience of leading and/or working with a global team in a matrix environment, including the management of virtual teams and strong experience leading teams and building capabilities
• Experience in developing effective working relationships with internal and external stakeholders
• Strong negotiation and conflict resolution skills and enterprise mindset, demonstrated by ability to drive for aligned solutions for SSO and GCO
• Strong project management skills and demonstrated ability to meet timelines
• Proven track record in trial operations process improvement(s)
You’ll receive:
Competitive salary, Annual bonus, Strong Work/Life Balance, flexible working, Top UK Employer, Pension scheme, Share scheme, Paid holidays, Comprehensive Medical Insurance, Subsidised Canteen, Employee Recognition Scheme, Sports & Social Club, Learning and development opportunities.
Why consider Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
https://www.novartis.com/about/strategy/people-and-culture Imagine what you could do at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
We are Novartis. Join us and help reimagine medicine.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Development
GCO GDD
United Kingdom
National
Novartis Pharmaceuticals UK Lt
Research & Development
Full Time
Regular
No
