This is a fully remote position, open to applicants in Bulgaria, +2 more countries.

📋 Description

• Collaborate with the Project Manager to ensure successful project delivery through the coordination and supervision of the cross-functional project team.

• Promote effective team communications and maintain both internal and external project documentation.

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

• Arrange internal and external team meetings, create agendas, record minutes, and manage action and decision logs.

• Produce and distribute study newsletters as needed.

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

• Ensure projects are ready for audits.

• Establish and manage necessary project systems, SOP indices, and study team lists.

• Administer 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 with a minimum of 2 years of clinical research experience.

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

• Fundamental understanding of ICH/GCP regulations.

• Basic familiarity with FDA guidance documents, EU directives, and ISO14155 regulations.

• Basic knowledge of drug/device development and clinical monitoring procedures.

• Basic understanding of project management terminology and guidelines.

• Proficient computer skills in the MS Office suite.

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