Job Description

About the 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.

YOUR KEY 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
• 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

Role Requirements

WHAT YOU\'LL BRING TO THE ROLE:

• Advanced or Bachelor\'s degree in life sciences/healthcare or clinical relevant degree (or equivalent). 12- 15 years of Industrial 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?

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!
Imagine what you could do here 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 hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Functional Area

Research & Development

Division

Global Drug Development

Business Unit

GCO GDD

Employment Type

Regular

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No

Novartis