
Project Support Specialist
Posted 5 days ago

Posted 5 days ago
This is a fully remote position, open to applicants in Poland, +4 more countries.
• Develop and manage project timelines using MS Project or comparable software, ensuring updates are documented and shared.
• Organize internal and external meetings; prepare and distribute agendas and minutes; maintain records in the Trial Master File.
• Carry out activities related to the Clinical Trial Management System, including tracking milestones, maintaining contact lists, enrollment forecasts, and handling helpdesk tickets.
• Prepare, assign, and document training specific to studies; maintain training records and identify any training gaps.
• Create and oversee study-specific SharePoint sites or equivalent shared workspaces and manage access permissions.
• Set up project-specific email accounts and control access.
• Manage user permissions for study systems and document regular access reviews.
• Procure study supplies and address associated inquiries.
• Order, prepare, compile, and ship initial study binders.
• Maintain study trackers as directed by project leadership.
• Communicate with study sites, investigators, and others, including sending SUSARs, email notifications, and newsletters.
• Assist in the distribution and monitoring of IND Safety Reports, SUSARs, and CIOMS.
• Facilitate the translation of site-level documents in accordance with local and regional standards.
• Serve as the main contact for project-related inquiries from team members, sponsors, and third-party vendors.
• Assist in the preparation, distribution, and reconciliation of study materials.
• Aid in the production of study reports and updates.
• Execute other tasks assigned by project leadership.
• Bachelor's degree or equivalent experience, preferably in a business, scientific, or healthcare field.
• At least 2 years of applicable experience as a Clinical Trial Assistant, Clinical Support Specialist, or a similar role.
• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, and PowerPoint).
• Customer-oriented attitude; adaptability, teamwork, and meticulous attention to detail.
• Advanced proficiency in English, both spoken and written.
• Familiarity with ICH-GCP, Precision SOPs, and relevant regulatory guidance.
• Strong interpersonal abilities.
• High self-motivation with the capacity to work and plan both independently and collaboratively.
• Excellent written and verbal communication skills.
• Dedication to maintaining professional standards in alignment with Precision Principles.
• Discretionary annual bonus.
• Private medical insurance.
• MultiSport Card.
• Life insurance.
• Pension plan.
• Home working allowance.
• Vacation time.
• Additional benefits.
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