393213BR
Mar 04, 2024
Czech Republic
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.
About the Role:
As a Clinical Project Manager, you will be responsible for coordinating and managing all aspects of assigned clinical studies, from early phase to late phase. This includes both interventional and non-interventional studies, as well as other clinical services such as managed access programs, research collaborations, and digital solutions.
Working under the lead of the Senior Clinical Project Manager, you will collaborate with a team of experts to plan and implement all operational aspects of the studies. From concept to reporting and manuscript writing, you will ensure that timelines, budgets, and quality standards are met, following required procedures.
In addition to handling the studies, you will also play a crucial role in fostering ongoing and effective collaboration with colleagues, customers, and other line functions. You will track performance and quality aspects, ensuring that all stakeholders are satisfied with the services provided by CONEXTS.
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.
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
About the Role:
As a Clinical Project Manager, you will be responsible for coordinating and managing all aspects of assigned clinical studies, from early phase to late phase. This includes both interventional and non-interventional studies, as well as other clinical services such as managed access programs, research collaborations, and digital solutions.
Working under the lead of the Senior Clinical Project Manager, you will collaborate with a team of experts to plan and implement all operational aspects of the studies. From concept to reporting and manuscript writing, you will ensure that timelines, budgets, and quality standards are met, following required procedures.
In addition to handling the studies, you will also play a crucial role in fostering ongoing and effective collaboration with colleagues, customers, and other line functions. You will track performance and quality aspects, ensuring that all stakeholders are satisfied with the services provided by CONEXTS.
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.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
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.
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-culture
You’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-rewards
Join 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/network
- 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-culture
You’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-rewards
Join 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/network
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
Operations
Global Business Solutions
Czech Republic
Prague
NOV CZE
Research & Development
Full Time
Regular
No
