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

📋 Description

• Oversee and execute start-up activities for designated studies at both country and site levels.

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

• Handle official communications with authorities and create RFI submission packages.

• Provide guidance to study teams regarding local legislation and import/export regulations.

• Modify trial materials, including Informed Consent Forms (ICFs), labels, and patient documents, to meet local requirements.

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

• Assist in contract negotiations with sites and institutions.

• Manage translation requests and review translations of trial documentation in the local language.

• Update study management databases and organize trial correspondence in the Trial Master File (TMF) according to Standard Operating Procedures (SOPs) and study plans.

• Maintain continuous status updates with study teams, sites, and study project management teams.

⛳️ 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 experience in start-up activities in Estonia, managing submissions under the Clinical Trials Regulation (CTR) via the Clinical Trials Information System (CTIS).

• Strong understanding of clinical research regulatory requirements at both local and global levels according to Good Clinical Practice (GCP).

• Proficient user of the Microsoft Office Suite.

• Excellent attention to detail and strong time-management skills.

• Ability to work collaboratively within study teams and with clients/vendors as needed.