Clinical Project Manager
Novartis
- Praha
- Trvalý pracovní poměr
- Plný úvazek
- 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.Role RequirementsEssential 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.Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-cultureYou'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.https://www.novartis.com/careers/benefits-rewardsJoin our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/networkFunctional AreaResearch & DevelopmentDivisionOperationsBusiness UnitGlobal Business SolutionsEmployment TypeRegularCommitment to Diversity & Inclusion:We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Shift WorkNoEarly TalentNo