Project Support Specialist

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

📋 Description

• Develops and maintains the project timeline using MS Project or a similar platform. Ensures that updates are accurately captured and documented, and disseminates these updates to study team members.

• Organizes both internal and external meetings, assists in preparing and distributing agendas, takes meeting minutes, 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 maintaining study milestone dates, updating study contact lists, managing enrollment projections as necessary, and submitting helpdesk tickets while ensuring resolution is completed.

• Prepares, assigns, and documents training specific to the study in relevant systems; oversees the upkeep of training records. Identifies training gaps and collaborates with team members or escalates issues as required.

• Establishes a study-specific SharePoint site or equivalent shared workspace, ensuring appropriate access for study team members, sponsors, and other relevant parties.

• Creates 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 similar services, periodically reviewing team member access, and documenting the access review process.

• Procures study supplies and addresses inquiries related to them.

• Orders initial study binders, collects and organizes materials, and ensures proper shipping to designated locations via printing vendors.

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

• Communicates with study sites, investigators, and others as instructed by the Project Manager, Clinical Trial Manager, or other Project Leadership, including SUSARs, email blasts, newsletters, and any other needed information.

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

• May facilitate the translation process for site-level documents as required, in accordance with local and regional standards.

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

• Aids in the preparation, distribution, and reconciliation of study materials during relevant phases of the study (e.g., 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 similar role.

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

• Strong customer service orientation; demonstrates adaptability, teamwork, and meticulous attention to detail.

• Capable of effectively communicating both verbally and in writing in English at a professional level.

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

• Exhibits strong interpersonal skills.

• Demonstrates high self-motivation, is detail-oriented, and can work independently as well as collaboratively within a team environment.

🏝️ Benefits

• Health insurance

• Flexible work arrangements