Parexel
10,000+ employees
Founded 1983
âïž Healthcare Insurance
𧏠Biotechnology
đ Pharmaceuticals
đ° Venture Round on 1990-01
Healthcare Insurance âą Biotechnology âą Pharmaceuticals
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
Senior Clinical Study Administrator
đ„ 0 minutes ago
đŁïžđčđ· Turkish Required
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Parexel
10,000+ employees
Founded 1983
âïž Healthcare Insurance
𧏠Biotechnology
đ Pharmaceuticals
đ° Venture Round on 1990-01
Healthcare Insurance âą Biotechnology âą Pharmaceuticals
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
đ Description
âą Lead and manage ongoing regulatory submissions and maintenance activities âą Prepare, review, and track regulatory documents for submission to Ethics Committees, IRBs, and Regulatory Authorities âą Ensure timely and compliant submission of all required documentation âą Oversee the setup, population, and maintenance of the ISF with meticulous attention to detail âą Manage oversight and follow-up of budget and contract amendments âą Demonstrate solid understanding of local regulatory and Ministry of Health procedures, including ethics and regulatory processes âą Work closely with CRAs, study teams, and regulatory specialists to ensure seamless coordination between clinical operations and regulatory functions âą Contribute to the production and maintenance of study documents, ensuring template and version compliance
đŻ Requirements
âą Strong involvement in ongoing regulatory submissions and lifecycle management, including amendments and maintenance activities âą Solid knowledge of local regulatory environment, including Ministry of Health procedures and ethics submission processes in TĂŒrkiye âą Experience in preparing, tracking, and following up on contract and budget amendments âą Focus on regulatory, documentation, and contract activities, with no direct involvement in payment processing âą This role requires a structured and detail-oriented professional with strong regulatory awareness rather than purely administrative support âą Ability to work in a structured, detail-oriented manner with strong emphasis on compliance and regulatory accuracy âą Working knowledge of the clinical study process and ICH-GCP guidelines âą Previous administrative experience in the medical/life science field âą Proficiency in written and spoken Turkish and English.
đïž Benefits
âą Competitive compensation and comprehensive benefits package âą Opportunity for professional growth and career advancement âą Supportive, international work environment
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