Study Start-Up Specialist - FSP

Responsibilities

• Full ownership of country-level start-up activities from post-feasibility to site activation
• Prepare, Preparation, coordination and tracking of initial regulatory submissions
• Preparation, coordination and tracking of initial regulatory submissions
• Responsibility for initial contracts and start-up related budget activities
• Tracking of import licenses, IMP and study equipment delivery
• Oversight of ISF preparation and site readiness.
• Essential Qualifications & Experience:
• Bachelor's degree in life science or a related discipline
• Good knowledge of ICH-GCP and relevant local regulations
• Proven experience in clinical trial start-up activities at country level, with end-to-end involvement from feasibility completion through site activation
• Basic understanding of the drug development process
• Strong hands-on experience in preparing, coordinating, and managing initial regulatory submissions
• Demonstrated ownership of start-up timelines, with the ability to track, manage, and drive site activation milestones
• Proven ability to identify start-up risks, manage competing priorities, and implement solutions to ensure timelines are met
• Experience supporting or overseeing study start-up budgets and financial aspects related to activation
• Good understanding of local regulatory environment and Ministry of Health procedures
• Solid understanding of Import License processes and regulatory requirements relevant to clinical trials
• Experience coordinating Investigational Product (IMP) and study equipment delivery to sites Strong knowledge of essential documents and ability to ensure site readiness, including ISF preparation and inspection readiness
• Fluency in Turkish and English (written and spoken)
• Good verbal and written communication skills
• Strong organizational and time management skills .
• Why Join Parexel
• Parexel is a leading global clinical research organization with a commitment to advancing clinical research and improving patient outcomes.

Benefits

Additional Information

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 Study Start-Up Specialist (SSU Specialist) to join our FSP Clinical Operations team (fully outsourced to work for one of the largest Pharmaceutical company). This role offers flexible working arrangements with two days per week at the Sponsor's office in either Istanbul or Ankara.

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