Project Support Specialist

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

📋 Description

• Develop and uphold project timelines using MS Project or comparable systems, ensuring documentation and distribution of updates.

• Organize both internal and external meetings, prepare and circulate agendas, record and distribute minutes, and maintain records in the Trial Master File.

• Manage data within the Clinical Trial Management System, including milestones, contact lists, enrollment forecasts, helpdesk tickets, and remediation efforts.

• Prepare, assign, document, and oversee study-specific training records; identify and escalate any training deficiencies.

• Create and maintain study-level SharePoint sites or similar collaborative workspaces, managing user access effectively.

• Establish project-specific email accounts and ensure appropriate access is maintained.

• Oversee user access to study systems and document periodic access evaluations.

• Procure study supplies and initial study binders; prepare, compile, and coordinate the shipment of binders.

• Maintain study tracking systems as directed by project leadership.

• Communicate with study sites, investigators, sponsors, and other stakeholders, including sending SUSARs, email updates, and newsletters.

• Assist in the distribution and monitoring of IND Safety Reports, SUSARs, and CIOMS documents.

• Facilitate the translation of site-level documents in accordance with local and regional standards.

• Serve as a primary contact for project-related inquiries from team members, sponsors, and vendors.

• Aid in the preparation, distribution, and reconciliation of study materials.

• Support the generation of study reports and updates, including those related to country/site initiation, activation, and recruitment.

• Execute other tasks as assigned by project leadership.

⛳️ Requirements

• Bachelor's degree or equivalent experience, preferably in a business, scientific, or healthcare field.

• At least 2 years of relevant experience as a Clinical Trial Assistant, Clinical Support Specialist, or a comparable role.

• Proficiency in Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.

• Capable of effective verbal and written communication in English at a proficient professional level.

• Familiarity with ICH-GCP, Precision SOPs, and applicable regulatory guidelines.

• Strong customer service orientation, adaptability, teamwork, and meticulous attention to detail.

• Excellent interpersonal skills.

• High level of self-motivation with the ability to plan and work both independently and collaboratively within a team.

• Exceptional written and verbal communication abilities.

• Dedication to performing in a manner that aligns with Precision Principles.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance plans.

• Opportunities for professional development and continuing education.

• Flexible working hours and remote work options.

• Supportive and collaborative team environment.