Project Support Specialist

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

📋 Description

• Develop and maintain project timelines using MS Project or comparable platforms; capture, document, and disseminate updates.

• Schedule both internal and external meetings; prepare and circulate agendas; record and distribute minutes; archive meeting records in the Trial Master File.

• Execute Clinical Trial Management System (CTMS) tasks, which includes maintaining milestones, contact lists, enrollment forecasts, and helpdesk resolution.

• Prepare, assign, and document training specific to the study; maintain training records and address any training deficiencies.

• Create and manage study-level SharePoint sites or similar collaborative workspaces and access permissions.

• Establish project-specific email accounts and oversee access management.

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

• Procure study supplies and address related inquiries.

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

• Maintain study trackers as directed by project leadership.

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

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

• Aid in the translation of site-specific documents.

• Serve as a point of contact for project-related inquiries.

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

• Contribute to the production of study reports and updates.

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

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

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

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

• Excellent interpersonal skills.

• Capability to work independently and plan effectively, as well as collaborate in a team setting.

• Strong written and verbal communication abilities.

• Dedication to performing in a manner consistent with Precision Principles.

🏝️ Benefits

• Discretionary annual bonus.

• Private medical insurance.

• MultiSport Card.

• Life insurance.

• Pension.

• Home working allowance.

• Vacation.

• Additional benefits.