Clinical Project Support SpecialistPosition purpose:
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The Clinical Project Support Specialist (CPSS) role is designed to provide comprehensive operational support to global study team. This role is pivotal inensuring the smooth execution of phase I-IV clinical trials by offering administrative, logistical, and operational on general level. The incumbent will workclosely with global study team members, and other key stakeholders on a global level to optimize study efficiency, compliance, and quality, contributing tothe timely regulatory submissions and market approval of new medicines and medical devices.
Geographical scope:Global
Legal entity:Euroservices Bayer
Major tasks of position:Administration & Logistics:
- Create and maintain different study documents and tools (e.g., Study Guide documentation, different study instructions, study newsletters, financialdisclosure summary tables, invoices) to support all different roles of the study.
- Create,
maintain, and manage multiple Study Contact Lists: Study/ Clinical Team, Vendor/ External suppliers, Study Organizations in Veeva.
- Update study Q&A; and Action log.-QSD tracker oversight (make sure that QSD list is available at certain, required timepoints).
- Set-up and maintain different project and study platforms/ software e.g., SharePoint/TEAMS, OneNote.
- Support Clinical/Study Team members with one ad hoc time tasks.
- Support audits and inspections according to company policy and SOPs.
EU - CTR:
- Support EU-CTR transition and all study submissions
Meeting support & communication
- Act as a Study Team key contact with eTMF Specialist / System Specialist.
- Support to set up and manage Clinical / Study Team and Steering Committee meetings e.g. preparing, drafting, presenting slides, recording, taking minutes and attendees list.
- Support organization of virtual/on-site Invest
📌 Clinical Project Support Specialist (Barcelona)
🏢 Bayer CropScience
📍 Barcelona
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