Study Start Up Manager

AstraZeneca; Fatih; On-site; TRY 50,000 - 70,000; Full time

Job summary

AstraZeneca is seeking a qualified candidate for country-level start-up activities in clinical trials based in Turkey. The ideal candidate will manage all aspects from regulatory submissions to site activation, ensuring activities are timely and compliant.

The role requires a Bachelor's degree in a life science field, fluency in both Turkish and English, and proven experience in managing clinical trial budgets and timelines. Join our diverse and inclusive team at AstraZeneca where we value varied perspectives.

Qualifications

• Proven experience in end-to-end clinical trial start-up activities.
• Strong hands-on experience in preparing regulatory submissions.
• Ability to identify start-up risks and manage timelines.

Responsibilities

• Full ownership of country-level start-up activities from post-feasibility to site activation.
• Prepare and track initial regulatory submissions.
• Oversight of ISF preparation and site readiness.

Skills

Knowledge of ICH-GCP and local regulations

Experience in clinical trial start-up activities

Fluency in Turkish and English

Strong organizational and time-management skills

Good verbal and written communication skills

Education

Bachelor's degree in life science or related discipline

Job description

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, coordinate, and track initial regulatory submissions
• Responsibility for initial contracts and start‑up related budget activities
• Track import licences, IMP and study equipment delivery
• Oversight of ISF preparation and site readiness

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.