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.
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.
Responsibilities:
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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
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Implementation of the SSU Strategy for assigned region during the study start up period
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Projecting site activation timelines and appropriately escalating when things get off track
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Adhering to process and tools designed to the support of the SSU team with day-to-day activities
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Leading the preparation of study level essential document templates
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Aiding in the preparation of content for Regulatory submissions
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Handling ICF negotiations and facilitating any required escalations
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Preparation and submission of IMP Release Packages
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Maintaining accurate and timely information in relevant clinical systems
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.
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Must have knowledge of clinical trial conduct
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General knowledge of drug development and ICH/GCP guidelines
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Requires proven project management skills
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Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
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Fluent in English.
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