Dec 17, 2021

Job Description

130,000! The average number of patients around the world that are actively participating in our clinical trials. As a member of our Trial Management team you will play an active role in ensuring patients have access to our clinical trials and make a difference in their lives.

Your Responsibilities:

• Contribute to all aspects of global clinical trial(s), under the oversight of the (Associate) Global Trial Director, to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead certain parts of global clinical trial(s).

• Be a core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress and issues/resolution plan at the CTT meeting and write minutes; coordinate and chair trial sub teams within the scope of his/her delegated responsibilities. Extended member of the Global Clinical Team (GCT).

• Contribute to the creation and execution of an operational risk management plan, highlighting potential risks and actions; Implement issue resolution plans and act as point of contact for all site-related issues and procedural questions, and lead interactions with relevant line functions including data management, drug supply management, clinical development and Novartis Country Organizations

• Development of study tools, guidelines and training materials as well as supporting the development of Case Report Forms (CRFs), and CRF completion guidelines. Ensure trial information/documents are reported within relevant trial repositories and tracking systems

• Contribute to the development of clinical outsourcing specifications to facilitate bid process and selection of Contract Research Organizations (CROs); lead interface with CROs in collaboration with outsourcing management and line functions; ensure vendors meet quality standards; contribute to the development/amendment of vendor contracts. Support the Global Trial Director with the development, management and tracking of the trial level life cycle budget.

Minimum Requirements

What you’ll bring to the role:

Advanced degree or equivalent education/degree in life science/healthcare recommended.

Fluent English (oral and written).

• 3-5 years of experience in clinical development with a minimum of 2 years in global clinical research. Involvement in cross-functional, multicultural and international clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities.
• Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
• Proven ability to work either independently or in a team setting, to meet goals by managing compliance, budget and timelines.
• Proven networking skills and ability to share knowledge and experience amongst colleagues.
• Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.
• Basic knowledge of appropriate therapeutic area.

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.

Why consider Novartis?

799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data.
Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons

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

Novartis Ireland Ltd. has been certified as a Top Employer 2020 by the Top Employers Institute for its exceptional employee offerings!

#LI-NOV = Novartis

Global Drug Development
Research & Development
Full Time
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Expert Global Trial Manager

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