Project Specialist

This is a fully remote position, open to applicants in Poland, +1 more country.

📋 Description

• Collaborate with the Project Manager to ensure successful project delivery by coordinating and overseeing the cross-functional project team.

• Facilitate communication among team members and maintain both internal and external project documentation.

• Keep updated contact lists for both internal and external project teams.

• Organize internal and external team meetings, create agendas, document meeting minutes, and oversee action and decision logs.

• Generate and distribute study newsletters as necessary.

• Oversee and monitor budgets associated with vendor projects, including managing supplies and invoices.

• Monitor out-of-scope services and assist in the preparation of Change Orders.

• Track supplies, invoices, and budgets related to vendor management activities.

• Ensure that projects are ready for audits.

• Develop and manage essential project systems, SOP indices, and study team lists.

• Handle study team/contact lists, system access requests, and email distribution lists.

⛳️ Requirements

• An Associate’s degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or a related field, along with a minimum of 2 years of clinical research experience.

• Alternatively, a Bachelor’s degree or international equivalent, preferably in a clinical, biological, scientific, business, or health-related discipline, with at least 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management preferred.

• Basic understanding of ICH/GCP regulations.

• Familiarity with FDA guidance documents, EU directives, ISO14155 regulations, drug/device development, and clinical monitoring procedures.

• Basic understanding of project management terminology and guidelines.

• Proficient computer skills in the MS Office suite are required.

• Must be available immediately or with only a short notice period to be considered.

• This position is offered as a 1-year Fixed Term Contract on Premier Research payroll.

🏝️ Benefits

• Health insurance

• Life insurance

• Retirement plan

• Paid time off

• Employee Assistance Program

• Flexibility and balance to support your life requirements