Site Excellence Partner (SEP)

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 . • Apply knowledge of data and analytics to target site and study, recommend and implement actions for mitigation and control • Conduct and report oversight activities, both remote and onsite visits, according to Client requirements and standardsQualificationsSkills and Education: • A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology • In general, candidates for this job would hold the following levels of education/experience: BS/BSc/MS/MSc or equivalent + 4 years of clinical research experience • Skills in more than one language are an advantage in this role; English is essential • 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) • Project management experience preferred in the clinical development area • Ability to lead, troubleshoot and influence for delivery • Independent approach • 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