.This job is with Bayer UK & Ireland, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.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.[[ext Title]] Position purpose: The Clinical Project Support Specialist (CPSS) role is designed to provide comprehensive operational support to global study team.This role is pivotal in ensuring the smooth execution of phase I-IV clinical trials by offering administrative, logistical, and operational on global level.The incumbent will work closely with global study team members, and other key stakeholders on a global level 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, different study instructions, study newsletters, financial disclosure 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., Share Point/TEAMS, One Note.-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 e TMF 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 Investigator meetings / Monitor meetings / Study Team meetings (e.G., Start-Up Camps and KOMs, weekly Study Team meetings, CLM's meetings) -Contribute to departmental / company initiatives and special projects.Provide expertise and support project planning, project management and implementation of functional initiatives to improve processes
