Job ID283673BRPosition TitleSenior Clinical Risk ManagerApply to Job
Job Description
500+! That’s the number of clinical trials that our associates in Global Development Operations (GDO) support.
As a Senior Clinical Risk Manager you will actively work with the Head of GDO Risk Management in the strategic development of the clinical risk management group. You will contribute to the pro-active and continuous improvement of quality, data integrity and general regulatory / ICH-GCP requirements across Global Development Operations (GDO) by leading the identification and mitigation of relevant cross-functional, systemic risk and issue trends.
Your Responsibilities:
• Supports the establishment and strategic development of the clinical risk management group in the GDO Risk Management Office (RMO).
• Supports the development of appropriate tools, frameworks and governance platforms that support collaboration amongst, and risk and issues trending and reporting by the RMO and the functional quality and compliance related groups in GDO.
• Identifies data sources for trending for cross-functional, systemic risks and issues and finds opportunities and methodologies how to access and investigate that data. Screens data for possible trends to identify areas that pose a quality risk to future portfolio activities if not mitigated.
• Performs/leads data-driven risk assessments and root cause analyses to identify which areas in particular need to be improved to avoid repetition of cross-functional, systemic quality issues moving forward.
• Leads cross-functional teams in identifying, planning and implementing appropriate mitigation plans.
• Ensures that improvements are measurable and that effectiveness checks will be in place.
• Tracks progress of mitigation plans and their implementation for cross-functional risks as well as high-impact functional risks. Tracks whether improvement targets are met and where not raises it for further action.
Minimum requirements
What you’ll bring to the role:
• Bachelor degree in life science, quantitative science or business
• Fluent in English (oral & written)
• 5+ years of experience in clinical operations
• 3+ years of experience in a risk management, quality management, process improvement or related role
• Thorough understanding of the drug development process and ICH-GCP requirements
• Experience with data mining/analysis, basic statistical methodologies as well as root cause analyses
• Ability to think independently and out of the box and able to assess and resolve complex problems
• Excellent project management skills with track record of leading projects to successful conclusion
• Proficient communication, influencing and negotiating skills.
• Proven ability to work independently in a complex matrix environment (including remote or virtual team environment).
• Experience in developing effective working relationships with internal and external stakeholders.
• Organizational awareness, including experience working cross-functionally and in global teams.
Why consider Novartis?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.DivisionGlobal Drug DevelopmentBusiness UnitGDO GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular
