Senior Clinical Operations Leaderp

Detalles de la oferta

.ParexP is currently hiring a Senior Clinical Operations Leader to join our team in.Position Purpose:The Sr Clinical Operations Leader has responsibilir one or more studies of moderate complexity generally with responsibilir all study management aspects of assigned studiesLeads and manages the tactical execution of one or more clinical studiom study startup through database release and inspection readiness to ensure timely delivery of study data.Provides oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study executionMay also input to and support compilation of sections to Clinical Study ReportsWill provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountabilir detailed study start-up and monitoring plans ar delivery to the agreed plansThe SCOL is a core member of the Study Team and will represent the CRO on matters of study executionWorks winctional lines and directly with CRO linctions to resolve or triage site level issuesWill drive decision making and work closely with the Clinical Study Team Lead (CSTL) to provide input to operational strategyFor studies where more than one SCOL is assigned, may be required to act as lead SCOL and will coordinate activities of the other SCOL's assignedOrganizational Relationships:Reports to the ParexP assigned Line Management with day-to-day directiom Client. Refer to Organizational Char details regarding assigned role and associated reporting structureIn addition to responsibilitir working with other COLs, the SCOL will be responsibr liaising with members of the project team and other cronctional lines as requirr technical system and process expertise and Therapeutic Area (TA) operational knowledgePrimary Duties:Operational Study Managemer one or more studies of moderate complexity generally with responsibilir all study management aspects of assigned studies.Accountabr the development of realistic detailed study start-up and monitoring plansAccountabr conducting country levasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plansCoordinates study/protocol training and Investigator MeetingsAccountabr the delivery of the study against approved plansLeads inspection readiness activities related to study management and site readinessMay produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriateMay expand study design document into approved protocol template while incorporating inpom other team members (e.G., Clinician, Clinical Pharmacology Lead, Supply Chain (SC) Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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