Senior Clinical Risk Manager

Hobson Prior are looking for a Senior Clinical Risk Manager to join a world-wide pharmaceutical company based in Switzerland. Our client focuses on providing pioneering medical solutions to improve the quality of people's lives. This position supports the pro-active and continuous improvement of quality, data integrity and general regulatory / ICH-GCP requirements across Global Development Operations.

Job Responsibilities:

• Supports the establishment and strategic development of the clinical risk management group in the GDO Risk Management Office.
• 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.
• 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.
• Identifies data sources for trending for cross-functional, systemic risks and issues and finds opportunities and methodologies on 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.
• 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.
• 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, leads cross functional teams in identifying, planning and implementing appropriate mitigation plans.
• Aligns with the process excellence groups across GDO and beyond to ensure that any function-specific risk and issue trends that were incidentally identified.
• 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.

Key Skills:

• 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, negotiating skills.
• Proven ability to work independently in a complex matrix environment (incl. remote or virtual team environment).
• Organizational awareness, including experience working cross-functionally and in global teams.

Requirements:

• A minimum of 5+ years of experience in clinical operations.
• A minimum of 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.
• Experience in developing effective working relationships with internal and external stakeholders.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.