(Senior) Clinical Risk Manager - Basel
Jocelyn Blackham is recruiting for a (Senior) Clinical Risk Manager to join a global pharmaceutical company based at their site in Basel on a 12 month contract.
The main purpose of the role will be to:
- Support the pro-active and continuous improvement of quality, data integrity and general regulatory/ICH-GCP requirements across Global Development Operations (GDO).
- 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.
- 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).
Further responsibilities will include:
- Supporting 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).
- Contributing to the development and maintenance of an appropriate issue and risk registry for systemic quality risk and issue trends across GDO. May act as owner of the registry and/or relevant content.
- Analyzing 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. Brings results forward to GDO QRB to agree on route of action.
- Tracks progress of mitigation plans and their implementation for cross-functional risks as well as high-impact functional risks.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Bachelor degree in life science, quantitative science or business.
- Fluent in English (oral & written).
- Previous experience in clinical operations.
- Previous hands on 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.
This is an excellent opportunity to join a well-established, pharmaceutical leader.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email firstname.lastname@example.org. Please could you send any correspondence in English. Please quote reference 47274 in all correspondence.