Site Excellence Partner (UK)

The Site Excellence Partner (SEP) is accountable for safeguarding the quality and patient safety at the investigator site and is responsible for site and monitoring oversight.The SEP is 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 risksThe SEP is accountable for identifying Clinical Research Associate (CRA) performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in placeThe SEP may be required to support some or all of the primary responsibilities of the Site Relationship Partner (SRP), as example, proactively collaborating and providing local intelligence to country outreach surveys, targeted sites strategies, study design, and Client pipeline opportunitiesThe SEP may be required to support additional primary responsibilities of the SRP in study start up, activation, and execution to the plan for targeted sites, helping coordinate with other roles and functions that will interface with target sites, thereby, simplifying site Client communications and enhancing overall visibility into and confidence of quality of site-level activitiesOrganizational Relationships:Reports to ExecuPharm-assigned Line Management with day-to-day direction from Client; refer to Organizational Chart for details regarding assigned role and associated reporting structureLiaises with cross-functional lines as appropriate: Signal Interpretation Leads; Process, Standards & Signal Interpretation Group Lead; SRP; and Study ManagerCoordinates with Provider at the site/country levelQualificationsRequirements:A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodologyIn general, candidates for this job would hold the following levels of education/experience: BS/BSc/MS/MSc or equivalent + 4 years of clinical research experienceSkills in more than one language are an advantage in this role; English is essentialSolid knowledge of clinical development processes with strong emphasis on monitoringDemonstrated 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 areaAbility to lead, troubleshoot and influence for deliveryIndependent approachDemonstrated knowledge of clinical research processes and global and local regulatory requirements; ability to gain command of process detailsDemonstrated ability to work in cross-functional matrix environmentAbility to evaluate, interpret and present complex issues and data to support assessment and mitigation of site riskEffective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organizationConsiders stakeholders including regulatory agencies and marketing when developing strategies and future directions