Study Start Up Manager

AstraZeneca; Şişli; On-site; TRY 180,000 - 320,000; Full time

Job summary

AstraZeneca Türkiye is seeking a dedicated country start-up specialist to drive clinical trial start-up activities from feasibility through site activation. You will coordinate regulatory submissions, budget implications, and supplier logistics while ensuring compliance with ICH-GCP and local regulations.

The role requires fluency in Turkish and English, strong organizational skills, and the ability to manage timelines and risks.

Qualifications

• Bachelor's degree in life science or related discipline.
• Strong knowledge of ICH-GCP and local regulations.
• Experience in country-level clinical trial start-up from feasibility to site activation.
• Understanding of drug development process.
• Experience coordinating IMP and study equipment delivery; ISF prep and inspection readiness.
• Fluency in Turkish and English.
• Excellent written and verbal communication; strong organizational skills.

Responsibilities

• Full ownership of country-level start-up activities from post-feasibility to site activation
• Prepare, coordinate and track initial regulatory submissions
• Responsible for initial contracts and start-up budget activities
• Tracking of import licenses, IMP and study equipment delivery
• Oversight of ISF preparation and site readiness

Skills

Turkish fluency

English fluency

Regulatory coordination

Project coordination

Documentation management

Attention to detail

Education

Bachelor's degree in life science or related discipline

Tools

Regulatory databases

Budget tracking tools

Job description

About the Role

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, 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.

Why AstraZeneca?

A high performing team, we are united and motivated by our shared purpose – to push the boundaries of science to deliver life-changing medicines. We come to work each day to make a difference – to patients, society and our company. In our work we aim to bring wider benefits to society – building healthy communities and limiting our impact on the planet. We are committed to leading the quest to meet rising global demand for effective healthcare. The shared creativity through both internal and external collaboration unlocks challenges and brings new solutions. You will be valued. Not only for your unique contribution, skills and background, but because we recognise people are our greatest asset. Here we are dedicated to being a Great Place to Work. Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Where can I find out more?

• Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
• Follow AstraZeneca on Instagram https://www.instagram.com/astrazenecaturkiyekariyer/
• Visit our Careers Website: https://www.astrazeneca.com.tr/farkli-dusunen-ezber-bozan-deger-yaratan.html

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.