Study Start Up Manager

Job Description

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

Qualifications:

• 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.

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