CLINICAL PROJECT SUPPORT SPECIALIST

Clinical Project Support SpecialistWe 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 submissionsMeeting 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 systemsSystem 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)Competences• The clinical development study and project coordination activities are accomplished through a strong skillset, understanding of clinical development and global operating processes of drug development as well as in-depth knowledge of ICH-GCP and international regulations.• Bachelor’s degree or equivalent in a relevant field with +2 - 3 yrs. of experience in pharmaceutical industry, or clinical research/development.• Candidate must bring experience working with VEEVA System.• The incumbent must have the ability to manage multiple high-level parallel tasks; work unsupervised, have effective computer skills, possess the ability to apply new techniques and technology, have excellent knowledge of all Microsoft Office programs, and strong prioritization skills.• The incumbent must show high level of flexibility, willingness to support the team, be able to manage complexity and have good analytical and problem-solving skills• The incumbent must display excellent planning and organizational skills, innovativeness, and keen attention to detail and excellent follow through.• The incumbent must have strong interpersonal, communication and team working skills and must be able to manage high level professional relationships with internal and external customers, like international teams, 3rd parties and people in a global environment.• Excellent communication and interpersonal skills, with fluency in English (both written and oral). Additional language skills are a plus.• Familiarity / experiences with clinical trial management systems and eTMF.