Project Support Specialist

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

📋 Description

• Develop and sustain project timelines using MS Project or similar platforms, ensuring updates are documented and disseminated.

• Organize internal and external meetings; prepare and distribute agendas and minutes; archive records in the Trial Master File.

• Execute activities related to the Clinical Trial Management System, such as maintaining milestones, contact lists, enrollment forecasts, and helpdesk support.

• Prepare, assign, document, and supervise study-specific training records while identifying and escalating any training deficiencies.

• Set up study-level SharePoint sites or comparable workspaces and manage user access.

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

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

• Order necessary study supplies and initial study binders; prepare, collate, and coordinate shipping.

• Maintain study trackers as directed by project leadership.

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

• Contribute to the creation of study reports and updates, including country/site initiation, activation, and recruitment reports.

• Execute other duties as assigned by project leadership.

⛳️ Requirements

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

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

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

• Ability to communicate effectively in English, both verbally and in writing, at a professional level.

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

• A customer service-oriented attitude, adaptability, teamwork skills, and strong attention to detail.

• Excellent interpersonal skills.

• High degree of self-motivation and capability to work and plan independently as well as collaboratively in a team setting.

• Strong written and verbal communication abilities.

• Dedication to conducting oneself professionally in alignment with Precision Principles.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Supportive and collaborative work environment.