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Site Relationship and Excellence Partner (FSP)

Parexel International Corporation

Sweden - Any Region - Home Based

Position Purpose:

The Site Relationship and Excellence Partner (SREP) is the main Client point of contact for

investigative sites as well as accountable for safeguarding the quality and patient safety at the

investigator site. SREP 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, SREP 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. SREP is also accountable for identifying Clinical Research Associate (CRA) performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place.

The SREP is the face of Client and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and Client’s reputation is that of Partner of Choice. The SREP proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and Client pipeline opportunities. SREP is accountable for study start up, activation, and execution to the plan for targeted sites. In addition to being the main point of contact, the lead will help 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 activities

QualificationsSkills and Education: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 + 5 years of clinical research experience and/or quality management experienceSkills in more than one language are an advantage in this role; English is requiredSolid 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 deliveryExperience implementing centrally designed and developed initiatives on a local basisDemonstrated knowledge of quality and regulatory requirements for applicable countriesDemonstrated 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, Food and Drug Administration (FDA), or country-specific regulatory environmentDemonstrated success in prior scientific/technical/administrative rolesDemonstrated experience in site activationDemonstrated networking and relationship building skillsDemonstrated ability to manage projects and cross-functional processesAbility to communicate effectively and appropriately with internal & external stakeholdersAbility to adapt to changing technologies and processesAbility 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 directionsChallenges people to surpass themselves in reaching their objectives using innovative solutionsUtilizes and encourages innovative approaches to build and maintain a competitive advantageActs as a champion of change across the area/region/countries; uses facts, logic and personal credibility to influence the successful implementation of process improvementsBuilds wide networks and alliances; utilizes stakeholder input to develop strategic thinking and find opportunities for collaborationRespectfully challenges practices, decisions or ideas to uphold integrity and ethical standardsExhibits behaviours consistent with company values to colleagues at multiple locations with diverse culturesMotivates through example, commitment, loyalty and enthusiasmSeeks to develop an integrated view of key colleague issues to shape decisions and strategy development

Job posted: 2022-05-31