Study Specialist – 12 Month Contract Role
PE Global is currently recruiting for a Study Specialist for an initial 12 month contract role with a leading multinational Biotech client based in London.
The Global Study Operations organization is tasked with providing strategic direction on the feasibility, design, and conduct of Phase 1-4 and post‑approval studies and drives the delivery of high‑quality data to support the registration approval and post‑approval activities of our clinical development assets. The organization achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross‑functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.
Activities and Responsibilities
- 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
- Manage and resolve site related issues and risks escalated to BioMarin that can’t be resolved by CRO
- Contribute to identifying risks and mitigations
- Oversee the Clinical Trial Insurance process
- Support Study Manager to ensure timely delivery and handling of IP to the sites
- Attend internal Global Study Operations team meetings, vendor meetings, and/or cross‑function Study Execution Meetings 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
Requirements
- BS or higher in nursing, life or health sciences is preferred
- At least 5 years of experience
- Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.) teams
