For one of our clients in Brussels, we are currently looking for a "Regional Clinical Site Leader".
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 the company" and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and the company's reputation is that of "Partner of Choice."
- Usher investigator sites through site activation and study activities from study start up to close out.
- Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
- Act as the main point of contact for all site- and study-level questions, liaising with and escalating to appropriate teams to respond and resolve questions. Follow up and close issue status with investigators to ensure awareness of resolution.
- Provide enrollment support and ensure progress by responding to start up and recruitment issues from investigators, partner with study team to define and support recruitment initiatives at site / country level.
- Support local CRO representatives develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Site Excellence Partner and Study Management.
- Responsible for site and monitoring quality, regulatory and GCP compliance.
- Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
- Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation Leads in conjunction with local country intelligence to to proactively identify risks. Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control.
- Conduct and report oversight activities, both remote and onsite visits, according to the companies requirements and standards.
- Work with CRO CRAs, and other CRO colleagues as appropriate, to DRIVE resolution of oversight issues.
- Accountable for identifying site and CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of CAPAs to address these.
- Review of monitoring visit reports.
- Serve as key contributor to process improvement initiatives and may lead local area initiatives.
- Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner and Study Team.
- A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology.
- English (fluent) is required because most of the contacts are international. Because there will be contacts/visits in Belgium: an intermediate knowledge level in French and Dutch is required.
- Site Management/Monitoring (CRA) experience (preferred)
- Identifies and builds effective relationships with customers and other stakeholders
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
- Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards
- Motivates through example, commitment, loyalty and enthusiasm
- A balanced salary package based on your capabilities and experience, including meal vouchers.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16705