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At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Clinical Project Support Specialist Position purpose: The Clinical Project Support Specialist (CPSS) role is designed to provide comprehensive operational support to global study teams. This role is pivotal in ensuring the smooth execution of phase I-IV clinical trials by offering administrative, logistical, and operational support on a global level. The incumbent will work closely with global study team members and other key stakeholders to optimize study efficiency, compliance, and quality, contributing to the timely regulatory submissions and market approval of new medicines and medical devices.
Geographical scope: Global
Major tasks of position: Administration & Logistics:Create and maintain different study documents and tools (e.g., Study Guide documentation, study instructions, study newsletters, financial disclosure summary tables, invoices).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.Set-up and maintain different project and study platforms/software e.g., SharePoint/TEAMS, OneNote.Support Clinical/Study Team members with 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.Support organization of virtual/on-site Investigator meetings/Monitor meetings/Study Team meetings.Contribute to departmental/company initiatives and special projects.Operating trackers/reports:Maintain different study trackers to keep study information up to date.Create study specific reports (e.g., CART, Veeva, IRT).System management:Upload/file/review different study level documents in eTMF.Provide updates/reports on eTMF status.Support eTMF closure.Manage user accesses for different study systems.Maintain and update Veeva/Gemstone entries.Vendor/CRO handling:Support outsourced studies, maintain oversight of CRO eTMF, Veeva.Manage requests for different study materials and coordinate logistics.Contribution context: Individual contributor
Work interactions: The CPSS will interact on a global scale within the study team and clinical team, including various stakeholders.
Value added: The Clinical Project Support Specialist role is important for clinical trials conduct by ensuring operational excellence and compliance.
Qualifications and requirements: Bachelor's degree or equivalent in a relevant field with 1 year + of experience in clinical research/development ideally in the pharmaceutical industry.Experience working with VEEVA System is preferred.Ability to manage multiple high-level parallel tasks; effective computer skills; knowledge of Microsoft Office programs.High level of flexibility, willingness to support the team, and strong analytical and problem-solving skills.Excellent planning and organizational skills, attention to detail, and follow-through.Strong interpersonal, communication, and team working skills.Fluency in English (both written and oral); additional language skills are a plus.Location: Spain: Cataluña: Barcelona
Division: Enabling Functions
Reference Code: 820468
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