Clinical Risk Manager (m/f/d)

REFERENCE NUMBER:

471824/1

MY DUTIES:

- Support the establishment and strategic development of the clinical risk management group in the GDO Risk Management Office
- Support 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 (e.g. PCM groups)
- Contribute 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
- Contribute to the development and maintenance of an appropriate issue and risk registry for systemic quality risk and issue trends across GDO
- Identify data sources for trending for cross-functional, systemic risks and issues and finds opportunities and methodologies how to access and investigate that data
- Analyze available data sources on potential, GDO-relevant, cross-functional, systemic quality risk and issue trends and perform 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, perform 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
- Lead 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, lead cross-functional teams in identifying, planning and implementing appropriate mitigation plans
- Align 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 
- Track progress of mitigation plans and their implementation for cross-functional risks as well as high-impact functional risks

MY QUALIFICATIONS:

- Bachelor degree in life science, quantitative science or business
- Fluent in English (oral and written)
- Profound experience in clinical operations
- Proficient 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, negotiating skills
- Proven ability to work independently in a complex matrix environment (incl. 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 

MY BENEFITS:

- Dynamic and innovative market environment

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Marija Tomas

Reference number
471824/1

Contact
E-Mail: [email protected]