500+ active trials with 80,000+ patients in 200+ programs! These are the figures of Global Drug Development (GDD) you will contribute as Clinical Study Manager based at Novartis in Rotkreuz.
As part of the Trial Monitoring Organization (TMO) within GDD, this role is critical in ensuring Innovative Medicines Phase I-
IV studies are conducted in compliance with Novartis processes and regulatory requirements.
Your responsibilities include, but are not limited to :
You will perform high quality feasibilities for new studies in order to ensure participation of Switzerland in the right studies for our patients and physicians.
You will collaborate with relevant line functions in TMO and Medical at local and global level to develop the local study execution plan
You will ensure study start-up activities are conducted and completed on time, managing preparation of Ethics Committee (EC) submission packages, local adaptation / review of Informed Consent Forms (ICFs), engaging Regulatory Affairs for Health Authorities submissions, in conjunction with TMO stakeholders and Medical
You will drive the conduct of the study to ensure all study operational aspects are on track (in terms of timelines, budget, performance, quality), working in alignment with Clinical Research Associate (CRA) Manager
You will maintain a strong knowledge of the study protocol and evaluate potential challenges / risks within the protocol and operational aspects of the study;
assessing impacts, developing risk management plans and communicating / escalating to regions and / or global teams, as appropriate
You will support inspection readiness and submission preparation for monitoring related activities and assist with internal audits and HA inspections and ensure implementation of corrective actions within specified timelines
You will participate in multidisciplinary taskforces to support continuous improvement initiatives
What you’ll bring to the role
A degree in scientific or health discipline is required. Fluent English (oral and written). Ability to communicate in German and / or French
Minimum 5 years-experience in clinical research with study monitoring expertize. Study management experience is desired
Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution, including strong knowledge of international standards (GCP / ICH) and local Health Authorities regulations
Strong engagement and accountability
Ability to manage complexity and work in a matrix environment
Flexible and adaptable to change
817 million. That’s how many lives our products touched in 2018. 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.
We are Novartis. Join us and help reimagine medicine.