About this role
Join our expanding sponsor-dedicated team in Türkiye as a Start-Up Specialist based in Istanbul and play a key role in bringing innovative clinical research studies to life.
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This role offers the opportunity to work across a variety of therapeutic areas while gaining valuable experience and advancing your career within a global organization.
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Responsibilities:
- ### Oversight of SSU activities from receipt of a potential site list to site activation under the direction of a SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other site activation requirements
- ### Implementation of the SSU Strategy for assigned region during the study start up period
- ### Projecting site activation timelines and appropriately escalating when things get off track
- ### Adhering to process and tools designed to the support of the SSU team with day-to-day activities
- ### Leading the preparation of study level essential document templates
- ### Aiding in the preparation of content for Regulatory submissions
- ### Handling ICF negotiations and facilitating any required escalations
- ### Preparation and submission of IMP Release Packages
- ### Maintaining accurate and timely information in relevant clinical systems
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Qualifications:
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- ### BS/BA degree or Associates degree with ≥2 years of experience in the health care field or direct clinical trial related experience.
- ### Must have knowledge of clinical trial conduct
- ### General knowledge of drug development and ICH/GCP guidelines
- ### Requires proven project management skills
- ### Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
- ### Fluent in English.
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