Title: Study Specialist II, Global Study Operations (GSO)
Duration: 12 months Contract on w2
Location: Hybrid or remote
Role Summary
The 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 Proactivity
Communication and Collaboration
Technical competencies:
Study Management and Execution
Compliance and Quality
Drug Development and Study Design
Product and Therapeutic Area Knowledge
Responsibilities 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 management
Contribute 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 warranted
Facilitate Screening Authorization Forms tracking/sign off where applicable
Manage various Global Study Operations document translations as applicable
Process 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 mitigations
Oversee the Clinical Trial Insurance process
Support Study Manager to ensure timely delivery and handling of IP to the sites
Support Vendor Management
Attend 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 meetings
Assist with filing GSO internal study documents in internal systems
Education & Experience
BS or higher in nursing, life, or health sciences is preferred Industry or relevant experience in lieu of education may be considered
Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)