Project Support Specialist

This is a fully remote position, open to applicants in Romania, +4 more countries.

📋 Description

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

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

• Keep track of study milestone dates, maintain contact lists, monitor enrollment forecasts, and manage helpdesk inquiries in the Clinical Trial Management System.

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

• Set up study-level SharePoint sites or equivalent shared workspaces and oversee user access.

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

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

• Procure study supplies and address supply-related inquiries.

• Order, prepare, compile, and dispatch initial study binders.

• 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 with the distribution and tracking of IND Safety Reports, SUSARs, and CIOMS.

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

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

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

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

• Perform additional duties 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 in a role such as Clinical Trial Assistant, Clinical Support Specialist, or a similar position.

• Proficiency in the Microsoft Office suite (Outlook, Word, Excel, and PowerPoint).

• Customer-oriented attitude; demonstrate adaptability, teamwork, and strong attention to detail.

• Ability to communicate effectively, both verbally and in writing, in English (Professional level).

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

• Excellent interpersonal skills.

• High level of self-motivation, attention to detail, and the capability to work independently as well as collaboratively in a team.

• Strong written and verbal communication skills.

• Dedication to performing professionally in line with Precision Principles.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Flexible work schedules and remote work options.