Job Description

About the role

Job Purpose.

Responsible for the execution and delivery of GCO supported clinical studies per the Operational Execution Plan (OEP) and clinical study protocol. The Study Leader is the leader of the cross-functional clinical trial team (CTT), guides planning and management of the assigned clinical study/studies end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT) and GCO objectives. Oversee budget and people allocation within assigned study/studies. Promotes operational excellence through process improvement and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs. Accountable for resolution of study management operational issues and impediments within assigned study/studies.

YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:

1. Leads the clinical trial team delivery of multiple global studies and promotes learning, sharing, consistent performance, and operational excellence through an agile mindset, agile principles, and an agile team of teams model
2. Acts as the CTT product owner with duties and responsibilities per the agile ways of working
3. Guides planning and decision making at the study level and delivers assigned clinical study/studies per the Operational Execution Plan (OEP) and clinical study protocol
4. Fosters an agile culture within assigned studies to achieve sprint goals and cycles, maximizing collaboration and minimizing dependencies in order to achieve long-term business impact
5. In collaboration with regulatory writing and clinical development, promotes operational excellence in the development of global clinical trial protocol(s), by translating the approved study concept sheet(s) into efficient, high quality, executable clinical protocols, and study-related documents
6. Create effective CTT dynamics and achieve on performance, prioritization, and communication in close collaboration with CTT sub-team leaders
7. Proactive risk management and inspection readiness
8. Responsible for developing clinical study timelines and overseeing assigned study budgets
9. Ensures systems are maintained with up-to-date study status, risks, and issues
10. Fosters a close working relationship with SSO Clinical Program Managers (CPMs) to strengthen the relationship between the global and local teams
11. Oversees study recruitment and responsible for activating mitigation strategies in collaboration with the SSO Clinical Program Managers (CPMs)
12. Fosters a close working relationship with the VPG Vendor Program Managers (VPMs) to strengthen the relationship between the vendors and CTT to deliver on clinical study objectives
13. Fosters a close working relationship with the CDO Trial Data Scientist (TDS) to deliver on clinical study objectives
14. Ensures proper handling of all study close out activities including but not limited to site close out, final drug accountability, and audit readiness of Trial Master File documentation
15. Promotes operational excellence and contributes to the development of Clinical Study Reports, reporting of clinical trial results, and internal/external publications, when appropriate
16. Partners and collaborates with PSP/Clinical Operations Program Head (COPH) to deliver clinical studies in alignment with program strategy
17. Achieves excellence in study operations and management through process improvement in collaboration with the Study Leadership Community Lead/Host and GCO Process, Training, and Compliance (PTC).

Role Requirements

WHAT YOU\'LL BRING TO THE ROLE:

Education (minimum/desirable):

• Bachelor\'s degree in life sciences/healthcare (or clinically relevant degree) is required. Advanced degree is preferred.

Experience/Professional requirements:

• \xe2\x89\xa5 2 years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV
• \xe2\x89\xa5 1 year of recent contribution to and accomplishment in all aspects of conducting clinical studies (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
• Experience in managing people globally in a complex matrix environment preferred
• Management of virtual teams. Proven ability and experience leading
• Experience in developing effective working relationships with internal and external stakeholders
• Strong communicator and presenter (oral and written)
• Strong organization and prioritization
• Strong negotiation and conflict resolution skills and enterprise mindset, demonstrated by ability to drive for aligned solutions for SSO and GCO/GDD
• Strong project management skills and demonstrated ability to meet timelines
• Strong strategic thinking with analytical and problem-solving skills
• Knowledge of appropriate therapeutic area preferred.

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