Beschreibung
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.He/she is responsible to analyze 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).
Experience/Professional requirement:
* 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.
If you have the experenice for this role please contact me
Hameda Khatun
Michael Bailey International is acting as an Employment Business in relation to this vacancy.