Site Relationship & Excellence Partner
Aixial Group is hiring in Brussels Region a Site Relationship & Excellence Partner consultant.
The role in a few words:
- The Site Relationship & Excellence Partner consultant will be the main point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site.
- The consultant is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies.
- As part of the oversight responsibilities, the consultant will utilize and interpret data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.
- The consultant is also accountable for identifying CRA performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place.
- The Site Relationship & Excellence Partner consultant is the face of our client and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved.
- BS/BSc/MS/MSc or equivalent
- + 7 years of clinical research experience and/or quality management experience.
- Fluent English, French and Dutch are required.
- Prior Experience in implementing centrally designed and developed initiatives on a local basis
- Solid knowledge of clinical development processes with strong emphasis on monitoring
- Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)
- Site Management/Monitoring (CRA) experience (preferred)
- Demonstrated knowledge of quality and regulatory requirements for applicable countries
- Demonstrated knowledge of site intelligence at country/cluster level in support of site recommendation
- Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment.