Clinical Risk Manager Process Improvement

Job Description

Your responsibilities include, but are not limited to: Contributes to the development and maintenance of a standard business process across GDO that aims at triaging and reporting of systemic quality issues and risks to the appropriate escalation and decision level. Contributes to the development and maintenance of an appropriate issue and risk registry for systemic quality risk and issue trends across GDO. Analyzes available data sources on potential, GDO-relevant, cross-functional, systemic quality risk and issue trends and performs a risk assessment considering at minimum frequency/likelihood of repeat occurrences and degree of impact. Brings results forward to GDO QRB to agree on route of action. Where the need for remediation is confirmed by GDO QRB, performs a data-driven root cause analysis to identify which areas in particular need to be improved to avoid repetition of cross-functional, systemic quality issues moving forward. Upon identification of key root causes of cross-functional, systemic risks and issues, contributes to cross-functional teams in identifying, planning and implementing appropriate mitigation plans. Ensures that improvements are measurable and that effectiveness checks will be in place. Aligns with the process excellence groups across GDO and beyond (e.g. GDD, NIBR, GMA) to ensure that any function-specific risk and issue trends that were incidentally identified while reviewing and scouting data have been or will be picked up by the respective functional group for further analysis and mitigation. 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. Contributes to the development / enhancement of GDO-wide key risk / quality. Contributes to the development of feedback loops with GDO associates on identified systemic issues, risks and planned mitigations to enable them to plan these in to their own project plans. May contribute to work streams and initiatives across Novartis.Minimum requirements Bachelor degree in life science, quantitative science or business Fluent in English (oral & written) 1. 3 - 5 years of experience in clinical operations 1 -2 years of experience in a risk management, quality management, process improvement or related role Good 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 complex problems Good project management skills. Proven networking skills and ability to share knowledge and experience amongst colleagues. Proven ability to work in a complex matrix environment (including remote or virtual team environment). 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. Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.,

Keyskills :
risk managementbanking riskcustomer relations complianceroot cause analysis environmental impact assessmentroot cause