Project Support Specialist

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

📋 Description

• Develops and oversees the project timeline using MS Project or a similar platform, ensuring that all updates are recorded and documented.

• Arranges internal and external meetings, assists in creating and distributing agendas, takes minutes during meetings, shares the minutes, and organizes meeting agendas and minutes in the Trial Master File.

• Engages in various activities 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 resolutions are achieved.

• Prepares, assigns, and logs study-specific training in relevant systems; oversees the upkeep of training records.

• Sets up a study-level SharePoint site or a similar collaborative space, ensuring appropriate access for the study team, sponsors, and other relevant parties.

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

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

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

• Orders initial study binders, gathers, organizes, and prepares these binders, ensuring they are shipped to the correct locations through the printing vendor.

• 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 directed by the Project Manager, Clinical Trial Manager, or other project leadership, including sharing SUSARs, email updates, newsletters, and other necessary information.

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

• May aid the translation process of site-level documents, as required, in line with local and regional standards.

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

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

• May provide support to team leaders in generating 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 a similar role.

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

• Strong customer service orientation; ability to demonstrate flexibility, teamwork, and meticulous attention to detail.

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

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

• Strong interpersonal skills.

• Exhibits high self-motivation, is detail-oriented, and able to work independently as well as collaboratively in a team environment.

• Excellent written and verbal communication abilities.

• Dedicated to performing duties in accordance with Precision Principles.

🏝️ Benefits

• Health insurance

• Competitive salary

• Flexible working hours

• Professional development opportunities