Senior Clinical Study Administrator

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

📋 Description

• Lead and oversee ongoing regulatory submissions and maintenance tasks.

• Prepare, review, and monitor regulatory documents for submission to Ethics Committees, IRBs, and Regulatory Authorities.

• Ensure all required documentation is submitted in a timely and compliant manner.

• Supervise the setup, population, and maintenance of the ISF with careful attention to detail.

• Manage the oversight and follow-up of budget and contract modifications.

• Exhibit a strong understanding of local regulatory and Ministry of Health protocols, including ethics and regulatory processes.

• Collaborate closely with CRAs, study teams, and regulatory specialists to ensure effective coordination between clinical operations and regulatory functions.

• Assist in the creation and upkeep of study documents, ensuring adherence to template and version compliance.

⛳️ Requirements

• Extensive involvement in ongoing regulatory submissions and lifecycle management, including amendments and maintenance activities.

• Strong understanding of the local regulatory landscape, including Ministry of Health procedures and ethics submission processes in Türkiye.

• Experience in preparing, tracking, and following up on contract and budget amendments.

• Focus on regulatory, documentation, and contract activities, without direct engagement in payment processing.

• This position requires a structured and detail-oriented professional with strong regulatory acumen rather than solely administrative support.

• Capability to work in a structured, detail-focused manner with a strong emphasis on compliance and regulatory accuracy.

• Familiarity with the clinical study process and ICH-GCP guidelines.

• Previous administrative experience in the medical/life sciences sector.

• Proficiency in both written and spoken Turkish and English.

🏝️ Benefits

• Competitive salary and a comprehensive benefits package.

• Opportunities for professional development and career growth.

• A supportive, international work atmosphere.