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 may includ
- e:Develop and/or review study specific documentation, as delegated by the Study Manag
- erContribute to the management of country and site feasibility assessme
- ntProvide support in the management of Regulatory document collection and tracking (in the absence of a CRO) for participating sit
- esContribute to the collection and oversight of essential documents for study life-cycle manageme
- ntContribute to the development of site and investigator training materia
- lsMay present at investigator meetings as assign
- edEnsure timely study entry and updates to ClinicalTrials.g
- ovEnsure investigator payment: site set-up, pass-through processing, visit payment processing and funding processing (in collaboration with payment vendo
- r)Provide administrative assistance with internal and external meetings including investigator meeting(s) as warrant
- edFacilitate Screening Authorization Forms tracking/sign off where applicab
- leManage various Global Study Operations document translations as applicab
- leProcess documents for signature in DocuSi
- gnSite management for delegated site(
- s)Manage and resolve site related issues and risks escalated to BioMarin that can’t be resolved by CR
- O.Contribute to identifying risks identification and mitigatio
- nsOversee the Clinical Trial Insurance proce
- ssSupport Study Manager to ensure timely delivery and handling of IP to the sit
- esSupport Vendor Manageme
- ntAttend internal Global Study Operations team meetings, vendor meetings, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requeste
- d.Oversee and manage essential documents in the Trial Master File (TM
- F)Contribute to Global Study Operations risks identification and mitigation
- s.Provide support and administrative assistance with internal and external meetin
- gsAssist with filing GSO internal study documents in internal system
s.Requireme
- ntsBS or higher in nursing, life or health sciences is prefer
- redIndustry or relevant experience in lieu of education may be conside
- redExperience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.) Te
amsPlease click the link below to ap
ply ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in
UK***…