343149BR
Apr 29, 2022
United Kingdom

Job Description

766 million. That’s how many lives our products touched in 2021. 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?

The Senior Clinical Risk Manager supports the pro-active and continuous improvement of quality, data integrity and general regulatory / ICH-GCP requirements across Global Development Operations (GDO). The Senior Clinical Risk Manager is responsible to support the identification and mitigation of relevant cross-functional, systemic risk and issue trends as well as track high-level the status of the investigation and remediation progress of high-impact, functional, systemic risk and issue trends.

Responsible for analyzing of available data sources for cross-functional, systemic issue and risk trends and to perform, or lead cross-functional teams to perform, data-driven and thorough root cause analyses followed by leading subsequent remediation activities (workstreams, initiatives, etc).

Your responsibilities:

Your responsibilities include, but are not limited to:

• Supports the establishment and strategic development of the clinical risk management group in the GDO Clinical Risk and Compliance (CRC) group.
• Supports the development of appropriate tools, frameworks and governance platforms that support collaboration amongst, and risk and issues trending and reporting by the CRC and the functional quality and compliance related groups in GDO (e.g. PCM groups).
• 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. May act as owner of that process.
• Contributes to the development and maintenance of an appropriate issue and risk registry for systemic quality risk and issue trends across GDO. May act as owner of the registry and/or relevant content Aim for eight bullet points
• 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.
• Acts as GDO Quality Review Board (QRB) secretary by proposing agenda topics, taking minutes, tracking actions and ensuring closure of follow-up activities and 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. Leads cross-functional teams in data-driven root cause analyses where the need for such a team is identified.
• Upon identification of key root causes of cross-functional, systemic risks and issues, 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.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• Bachelor degree in life science, quantitative science or business
• 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 with Excellent project management skills with track record of leading projects to successful conclusion
• Proficient communication, influencing, negotiating skills
• Fluent in English (oral & written)


You’ll receive:

Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

Why consider Novartis?
766 million. That’s how many lives our products touched in 2021. 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.

Imagine what you could do at Novartis!

For the Ninth consecutive year, Novartis been certified a ‘Top Employer’ in the UK (2014-2022)!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network


We are Novartis. Join us and help reimagine medicine.

#LI-NOV = Novartis
Global Drug Development
GDO GDD
United Kingdom
London-West
Ireland
Human Resources
Full Time
Regular
No
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343149BR

Senior Clinical Risk Manager

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