Clinical Project Support Specialist - Wodker Associates
21 hours ago
Barcelona
Clinical Project Support Specialist We are looking for a Clinical Project Support Specialist to work in a multinational company. Its products and services are designed to benefit people and improve their quality of life. 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. 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., 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 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. Operating trackers/reports • Maintain different study trackers to keep study information up to date and to ensure study oversight/quality at different study levels, including vendor trackers and logistics (e.g., EPRO translations, vendor manual, devices, lab kits etc.)., • Create study specific reports (e.g., CART, Veeva, IRT etc.), • Create and update other team study specific Trackers, that cannot be pulled from existing systems System management • Upload/file/review different study level documents in eTMF (from StM & SLM, but also from other functions if agreed with the Team)., • Provide updates/reports on eTMF status (in Study Team meetings/country calls/regular communications) and maintain oversight of eTMF quality/completeness (if agreed with the Team and depending on which reports that are provided by eTMF Specialist)., • Support eTMF closure (e.g. by ensuring availability of all documents uploaded to eTMF)., • Maintain IT systems list in Gemstone., • Manage user accesses for different study systems (internal/vendor systems or updating information for vendor system access/portals such as IRT, Central Lab, ePRO vendor, adjudication vendor, SharePoint restricted area, TEAMS channels)., • Maintain and update Veeva/Gemstone entries., • Support VST transition (Veeva Study Training ) and request Training log annual update for Study Team Members. Vendor/CRO handling • Support outsourced studies, maintain oversight of CRO eTMF, Veeva by ongoing QC in the systems if needed., • Manage requests for different study materials not provided by central labs /RR (bags, miniprotocols, manuals). Coordinate logistics (orders, shipments, custom clearance) of trial supplies for sites (e.g. eCOA device orders and shipments, laboratory kits, manuals, miniprotocols, medical equipments, RR materials -if requested)
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