Senior Clinical Project Manager

Summary

The Senior Clinical Project Manager lead a global study team responsible for the planning and implementation of all operational aspects of scientifically and operationally complex studies from study concept to clinical study report/manuscript writing, according to timelines, budget, operational and quality standards.

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.

• 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.