
Project Support Specialist
Posted 3 days ago

Posted 3 days ago
This is a fully remote position, open to applicants in Slovakia, +4 more states.
β’ Develop and uphold project timelines using MS Project or comparable software; document, communicate, and distribute updates regularly.
β’ Organize internal and external meetings; prepare and share agendas and minutes; archive records in the Trial Master File.
β’ Oversee study milestone dates, contact lists, enrollment forecasts, and helpdesk resolutions within the Clinical Trial Management System.
β’ Prepare, assign, document, and supervise study-specific training and training records; identify and escalate any training gaps.
β’ Set up study-level SharePoint sites or similar collaborative workspaces and manage user access.
β’ Create project-specific email accounts and ensure team access is maintained.
β’ Manage user access to study systems and conduct regular access reviews.
β’ Procure study supplies and address supply-related inquiries.
β’ Order, prepare, compile, and dispatch initial study binders.
β’ Maintain study trackers as instructed by project leadership.
β’ Communicate with study sites, investigators, and other stakeholders, including sending SUSARs, email updates, and newsletters.
β’ Assist in the distribution and monitoring of IND Safety Reports, SUSARs, and CIOMS.
β’ Aid in the translation of site-level documents in accordance with local and regional standards.
β’ Serve as a point of contact for project-related inquiries from team members, sponsors, and third-party vendors.
β’ Assist in the preparation, distribution, and reconciliation of study materials.
β’ Contribute to the production of study reports and updates, which include country/site initiation, activation, and recruitment reports.
β’ Perform additional tasks as assigned by the Project Manager, Clinical Trial Manager, or other project leaders.
β’ Bachelorβs degree or equivalent experience, preferably in a business, scientific, or healthcare-related field.
β’ At least 2 years of relevant experience as a Clinical Trial Assistant, Clinical Support Specialist, or a similar role.
β’ Proficiency in Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint.
β’ Ability to communicate effectively, both verbally and in writing, in English at a professional level.
β’ Familiarity with ICH-GCP, Precision SOPs, and regulatory guidelines.
β’ A customer-oriented attitude, adaptability, teamwork, and a strong attention to detail.
β’ Excellent interpersonal skills.
β’ High self-motivation and capability to work and plan independently as well as collaboratively in a team environment.
β’ Strong written and verbal communication abilities.
β’ Dedication to performing in a manner consistent with Precision Principles.
β’ Comprehensive health benefits package.
β’ Opportunities for professional development and growth.
β’ Flexible working hours and remote work options.
β’ Supportive team environment that fosters collaboration.
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