Summary
About the Role
Location: Czech Republic, Prague #LI-Hybrid
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Key Responsibilities:
- Collaborate with colleague/customer team and Line Functions to establish realistic project timelines. Escalate any unresolved disagreements to higher management.
- Lead and manage a multidisciplinary Clinical Trial Team (CTT), ensuring effective planning, evaluation, and implementation of assigned clinical studies and programs.
- Organize and facilitate investigators meetings and internal meetings related to study execution and operational excellence.
- Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study setup and conduct, monitor site performance, address protocol deviations, and resolve issues.
- Support compilation of study regulatory documents for submissions and assist with monitoring activities and communications with partners.
- Review site visit reports and monitor activities for quality control.
- Chip in to ongoing medical/scientific data quality review and coordinate data analysis and interpretation for first results.
- Assist in developing study protocols, treatment plans, informed consent forms, and other essential study documents.
- Contribute to clinical sections of regulatory documents and ensure approval from colleague/customer.
- Handle the writing or liaise with medical writing/narrative group to ensure completion of the Clinical Study Report.
- Set up and maintain the Trial Master File (TMF), Clinical Trial Management System (CTMS), and other required systems in collaboration with Clinical Operations Specialists.
Essential Requirements:
- Life Science degree or equivalent of education, training and experience
- Fluent English (oral and written)
- 10+ years of Clinical Operations experience with strong managerial experience in planning, driving, reporting and publishing clinical studies (interventional and non-interventional, early to late phase) in a pharmaceutical
- Confirmed ability to work independently, to lead a multidisciplinary cross-functional team in a complex matrix environment (including remote).
- Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process.
Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
