Souhrn
About the Role
Key Responsibilities:
- Collaborate with colleagues, customers, and line functions to establish realistic project timelines. Escalate issues to higher-level management if no agreement can be reached.
- Lead and manage a multidisciplinary cross-functional Clinical Trial Team or support the Senior Clinical Project Manager in planning and implementing clinical studies and programs.
- Organize investigators meetings and internal meetings related to clinical study execution.
- Interact directly with investigator sites, CRAs, CROs, and vendors to ensure smooth study set-up and conduct, monitor site performance, address protocol deviations, and resolve issues.
- Assist in the compilation of regulatory documents for submissions to authorities and ethics committees.
- Review site visit reports and ensure quality control of monitoring activities.
- Contribute to ongoing medical/scientific quality review of study data and coordinate data analysis and interpretation for initial results.
- Contribute to the development of study protocols, amendments, informed consent forms, and other essential documents.
- Manage study budgets and provide input for clinical outsourcing specifications.
- Identify areas for process or technology improvements and participate in continuous improvement initiatives.
Essential Requirements:
- Bachelor's degree or higher in life sciences or a related field, or equivalent combination of education, training, and experience.
- Approximately 8 years of experience in Global Clinical Operations, with managerial experience in designing, planning, executing, reporting, and publishing clinical studies, both interventional and non-interventional, across different phases.
- Proven ability to work independently in a complex matrix environment, including leading cross-functional teams.
- Strong project management skills.
- In-depth knowledge of Good Clinical Practice (GCP), clinical study design, statistics, regulatory processes, and the global clinical development process.
- Excellent spoken and written English.
- Excellent presentation and diplomacy skills, with the ability to negotiate and resolve conflicts.
Desirable Requirements:
- Ability to independently resolve issues and know when to escalate them
- Accountable and responsible in project and study management.
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
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