Project Support Specialist

This is a fully remote position, open to applicants in Poland.

📋 Description

• Develops and upholds the project timeline using MS Project or a similar platform. Ensures all updates are recorded and documented, facilitating the distribution of these updates to study team members.

• Organizes both internal and external meetings, aids in the preparation and distribution of agendas, takes minutes during meetings, circulates these minutes, and archives meeting agendas and minutes in the Trial Master File.

• Conducts various tasks within the Clinical Trial Management System (CTMS), including managing study milestone dates, updating contact lists, maintaining enrollment projections as necessary, and submitting helpdesk tickets while ensuring the completion of remediation.

• Prepares, assigns, and logs study-specific training in the appropriate systems; oversees and manages the upkeep of training records. Identifies training gaps and collaborates with relevant team members or escalates issues as necessary.

• Sets up a study-level SharePoint site or similar shared workspace and ensures appropriate access for study team members, sponsors, and others as required.

• Establishes project-specific email accounts and manages access for study team members.

• Oversees user access to study systems by submitting user requests to the Help Desk or a similar service, periodically reviewing team member access, and documenting the access review process.

• Procures study supplies and addresses inquiries related to these supplies.

• Orders initial study binders, collects and organizes materials, and ensures they are shipped to the correct locations via the printing vendor.

• Maintains various study trackers as directed by the Project Manager, Clinical Trial Manager, or another project leader.

• Sends communications to study sites, investigators, and others as directed by the Project Manager, Clinical Trial Manager, or other project leadership, including SUSARs, email blasts, newsletters, and other necessary information.

• May assist in the distribution and tracking of IND Safety Reports/SUSARs/CIOMS according to procedures outlined by the study team in the project plan, potentially under the guidance of Safety staff.

• May support the translation of site-level documents as applicable, adhering to local and regional standards.

• May serve as the primary contact for project-related inquiries from team members, sponsors, and third-party vendors.

• Aids in the preparation, distribution, and reconciliation of study materials during the relevant phases of the study (Operations Manual, ISF, patient cards, etc.) as necessary.

• May assist team leaders in producing various study reports and updates (e.g., country/site initiation, activation, recruitment).

• Performs additional duties as assigned by the Project Manager, Clinical Trial Manager, or other 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 in a comparable role.

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

• Exhibits a customer service-oriented demeanor; demonstrates flexibility, teamwork, and meticulous attention to detail.

• Strong verbal and written communication skills in English (Professional level).

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

• Possesses solid interpersonal skills.

• Demonstrates strong self-motivation, attention to detail, and the ability to work independently as well as collaboratively in a team environment.

• Excellent written and verbal communication abilities.

• Committed to maintaining professionalism in alignment with Precision Principles.

🏝️ Benefits

• Health insurance

• Flexible working hours

• Professional development opportunities