Beschreibung
We are recruiting for a Senior Clinical Risk Manager who will support continuous improvement of quality, data integrity and general regulatory requirements across Clinical Operations. You will be responsible for the identification and mitigation of relevant cross-functional, systemic risk and issue trends as well as track high-level investigation and remediation progress of high-impact, functional, systemic risk and issue trends.Responsibilities:
- Support the establishment and strategic development of the clinical risk management group.
- Support the development of appropriate tools, frameworks and governance platforms.
- Contribute to the development and maintenance of a standard business process across 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.
- Identify data sources 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.
- Analyse available data sources on potential, 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, you will 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. 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.
Requirements:
- BSc 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
- 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.
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.