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

📋 Description

• Execute and oversee start-up activities for designated studies at both country and site levels.

• Prepare, submit, and monitor initial applications and amendments to Competent Authorities and Ethics Committees (CA/CEC/LEC), IRBs, and other relevant organizations.

• Manage formal communication with authorities and ethics committees; develop response submission packages for authority inquiries.

• Provide guidance to study teams on local legislation and import/export requirements from a submission standpoint.

• Modify trial materials, including Informed Consent Forms (ICFs), labels, and patient documents, to comply with local country regulations.

• Assemble Investigational Product (IP) release and essential document packages to facilitate timely site activation.

• Assist in contract negotiations (CTAs) with sites and institutions.

• Handle translation requests and review translations of local-language trial documentation required for submissions.

• Update study management databases and organize trial correspondence in the Trial Master File (TMF) in accordance with SOPs and study plans.

• Maintain continuous status updates with study teams, sites, and the study Project Management team.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Nursing, or a related field.

• Proficiency in the English language.

• A minimum of 2-3 years of recent hands-on experience with start-up activities in Greece, managing submissions under the Clinical Trials Regulation (CTR) via the Clinical Trials Information System (CTIS).

• In-depth knowledge of clinical research regulatory requirements at both local and global levels in accordance with Good Clinical Practice (GCP).

• Proficient user of the Microsoft Office Suite.

• Strong attention to detail and effective time-management skills.

• Ability to collaborate and work effectively within study teams as well as with clients and vendors as necessary.