Senior Clinical Study Administrator

Parexel

Senior Clinical Study Administrator in clinical operations focusing on regulatory compliance. Managing ongoing submissions and budget oversight in partnership with a large pharmaceutical company.

Posted 6/23/2026full-timeRemote • 🇹🇷 TurkeySeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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
Oversee the setup, population, and maintenance of the ISF with meticulous attention to detail
Manage oversight and follow-up of budget and contract amendments
Demonstrate solid understanding of local regulatory and Ministry of Health procedures, including ethics and regulatory processes
Work closely with CRAs, study teams, and regulatory specialists to ensure seamless coordination between clinical operations and regulatory functions
Contribute to the production and maintenance of study documents, ensuring template and version compliance

Requirements

What you’ll need

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.

Benefits

Comp & perks

Competitive compensation and comprehensive benefits package
Opportunity for professional growth and career advancement
Supportive, international work environment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionslifecycle managementdocument preparationbudget amendmentscontract amendmentsregulatory complianceclinical study processICH-GCP guidelines

Soft Skills

detail-orientedstructuredregulatory awarenessstrong communication