Senior Clinical Study Administrator

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Are you passionate about advancing clinical research and making a real difference in patients' lives? Parexel is seeking an experienced Senior Clinical Study Administrator to join our FSP Clinical Operations team (fully outsourced to work for one of the largest Pharmaceutical company) and play a specialized role that bridges clinical administration with regulatory expertise, supporting ongoing studies with a focus on regulatory compliance and documentation excellence.

This is a remote position for candidates based in Istanbul or Ankara.

Key Responsibilities:
Regulatory Submissions & Maintenance: Lead and manage ongoing regulatory submissions and maintenance activities. Prepare, review, and track regulatory documents for submission to Ethics Committees, IRBs, and Regulatory Authorities. Ensure timely and compliant submission of all required documentation.
Investigator Site File (ISF) Management: Oversee the setup, population, and maintenance of the ISF with meticulous attention to detail. Ensure all essential documents are properly organized, tracked, and maintained in accordance with ICH-GCP guidelines and local regulatory requirements. Maintain ISF inspection readiness throughout the study lifecycle.
Budget & Contract Oversight: Manage oversight and follow-up of budget and contract amendments. Support contract preparation at the site level and ensure all contractual obligations are met and documented appropriately.
Regulatory Compliance & Documentation: Demonstrate solid understanding of local regulatory and Ministry of Health procedures, including ethics and regulatory processes. Ensure all study documentation maintains compliance with sponsor standards, local legislation, and ICH-GCP guidelines.
Cross-Functional Collaboration: Work closely with CRAs, study teams, and regulatory specialists to ensure seamless coordination between clinical operations and regulatory functions. Serve as a key liaison between the Local Study Team and regulatory authorities.
Document Management & Quality Control: Contribute to the production and maintenance of study documents, ensuring template and version compliance. Manage layout, language control, and distribution of regulatory and administrative documents.

What We're Looking For

Essential Experience:
- Strong involvement in ongoing regulatory submissions and lifecycle management, including amendments and maintenance activities
- Solid knowledge of local regulatory environment, 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, with no direct involvement in payment processing
- This role requires a structured and detail-oriented professional with strong regulatory awareness rather than purely administrative support
- Ability to work in a structured, detail-oriented manner with strong emphasis on compliance and regulatory accuracy 
- Working knowledge of the clinical study process and ICH-GCP guidelines
- Previous administrative experience in the medical/life science field
- Proficiency in written and spoken Turkish and English.

Why Join Parexel?
- Work with a global leader in clinical research and regulatory services
- Develop specialized expertise in regulatory submissions and compliance
- Collaborate with experienced clinical teams across multiple therapeutic areas
- Opportunity for professional growth and career advancement
- Competitive compensation and comprehensive benefits package
- Supportive, international work environment.

Parexel is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.