Site Excellence Partner

In Parexel FSP we are looking for a Site Excellence Partner based in Madrid/Barcelona area.

**Position Purpose**:

- Accountable for safeguarding the quality and patient safety at the investigator site and is responsible for site and monitoring oversight
- Responsible for utilizing and interpreting 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
- Accountable for identifying Clinical Research Associate (CRA) performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place

**Primary Duties**:
Responsible for process, standards and oversight for assigned studies
- Responsible for site and monitoring quality, regulatory and Good Clinical Practice (GCP) compliance
- Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution
- 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 proactively identify risks
- Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control
- Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.)
- Demonstrate use of data to enhance quality and accelerate study delivery.
- Conduct and report oversight activities, both remote and onsite visits, according to Client requirements and standards
- Perform additional oversight visits/reviews based on the type of issues that arise during the course of a study, and the analytics and visualizations outputs
- 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

Protocol Site Oversight
- Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality
- Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements

Site and Study Management Interface
- Support local Investigator relationship management with the Site Relationship Partner.
- Serve as point of contact for quality and safety escalations for Provider, CRAs, Site Relationship Partner and Study Team
- Support the resolution of operational obstacles at the site/country level in order to advance the site and study deliverables

**The Individual**:

- A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology
- Fluent Spanish and English
- Solid knowledge of clinical development processes with strong emphasis on monitoring
- Site Management/Monitoring (CRA) experience (preferred)
- Project management experience preferred in the clinical development area
- Ability to lead, troubleshoot and influence for delivery
- Demonstrated knowledge of clinical research processes and global and local regulatory requirements; ability to gain command of process details
- Demonstrated ability to work in cross-functional matrix environment
- Ability to evaluate, interpret and present complex issues and data to support assessment and mitigation of site risk
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
- Considers stakeholders including regulatory agencies and marketing when developing strategies and future directions
- Motivates through example, commitment, loyalty and enthusiasm
- Availability to travel regularly within country and region is required

LI-REMOTE