Project Support Specialist

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

📋 Description

• Develop and uphold project timelines using MS Project or equivalent platforms, documenting and disseminating updates.

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

• Track study milestone dates, contact information, enrollment forecasts, and helpdesk tickets within the CTMS.

• Prepare, assign, document, and supervise study-specific training along with maintaining training records.

• Create study-level SharePoint sites or comparable shared workspaces and manage user access.

• Establish project-specific email accounts and ensure proper access management.

• Oversee user access to study systems and document regular access reviews.

• Order study materials and initial study binders, prepare resources, and coordinate shipping logistics.

• Maintain study trackers as directed by project management.

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

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

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

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

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

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

• Carry out additional 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 similar role.

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

• High-level English proficiency in both verbal and written communication.

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

• Customer-focused approach, adaptability, teamwork, and meticulous attention to detail.

• Strong interpersonal abilities.

• High self-motivation with the capacity to plan and work independently as well as collaboratively within a team.

• Excellent written and verbal communication skills.

• Dedication to performing professionally in alignment with Precision Principles.

🏝️ Benefits

• Comprehensive health, vision, and dental insurance.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and growth.

• Collaborative and inclusive work environment.

• Competitive salary and performance-based incentives.