387241BR
Jan 29, 2024
Ireland

About the Role

Location - Hybrid working role
Associate Director level role

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.

Key responsibilities:
• 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
• Act as the CTT product owner with duties and responsibilities per the agile ways of working
• 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
• Create effective CTT dynamics and achieve on performance, prioritization and communication in close collaboration with CTT sub-team leaders
• 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
• Ensures proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit/inspection readiness of Trial Master File documentation
• 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

Essential requirements:

Required Experience & Qualifications:
• 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)

Why 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

You’ll receive:

Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

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

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
Ireland
Dublin
Research & Development
Full Time
Regular
No
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387241BR

Senior Study Leader

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