Clinical Study Specialist

Job Details:Title: Study Specialist II, Global Study Operations (GSO)Duration: 12 months Contract on w2 Location: Hybrid or remoteRole SummaryThe Study Specialist II (SS-II) contributes to or leads tasks related to the oversight of site monitoring, site management and/or vendor management, and other activities as delegated by the Study Manager. This may include contributing to and/or supporting study related matters that impact study timelines, quality, and budget. Within the role the candidate is expected to show and have proficient knowledge and experience in the following competencies:Core Competencies:Agility and ProactivityCommunication and CollaborationTechnical competencies:Study Management and ExecutionCompliance and QualityDrug Development and Study DesignProduct and Therapeutic Area KnowledgeResponsibilities include but are not limited to:Develop and/or review study-specific documentation, as delegated by the Study Manager Contribute to the management of country and site feasibility assessment Provide support in the management of Regulatory document collection and tracking (in the absence of a CRO) for participating sites Contribute to the collection and oversight of essential documents for study life-cycle managementContribute to the development of site and investigator training materials May present at investigator meetings as assigned Ensure timely study entry and updates to ClinicalTrials.gov Ensure investigator payment: site set-up, pass-through processing, visit payment processing and funding processing (in collaboration with payment vendor) Provide administrative assistance with internal and external meetings including investigator meeting(s) as warrantedFacilitate Screening Authorization Forms tracking/sign off where applicable Manage various Global Study Operations document translations as applicableProcess documents for signature in DocuSign Site management for delegated site(s)Manage and resolve site related issues and risks escalated to BioMarin that can't be resolved by CRO.?Contribute to identifying risks identification and mitigationsOversee the Clinical Trial Insurance processSupport Study Manager to ensure timely delivery and handling of IP to the sites Support Vendor ManagementAttend internal Global Study Operations team meetings, vendor meetings, and/or Cross-Function Study Execution Meetings (s) as GSO representative and take meeting minutes as requested. Oversee and manage essential documents in the Trial Master File (TMF) Contribute to Global Study Operations risks identification and mitigations. Provide support and administrative assistance with internal and external meetingsAssist with filing GSO internal study documents in internal systemsEducation & ExperienceBS or higher in nursing, life, or health sciences is preferred Industry or relevant experience in lieu of education may be consideredExperience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)

Created: 2024-11-07