Clinical Risk Manager
Posted on Jan 14, 2020 by Michael Bailey Associates - UK Contracts
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).
. 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
Michael Bailey International is acting as an Employment Business in relation to this vacancy.