Remotery

Project Support Specialist

Posted 3 days ago

This is a fully remote position, open to applicants in Slovakia, +4 more states.

πŸ“‹ Description

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.


⛳️ Requirements

β€’ Bachelor’s 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.


🏝️ Benefits

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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