Sobre esta vaga de Sponsor-Dedicated Start-Up Specialist in Türkiye na Fortrea
Fortrea · Presencial · Istanbul
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:
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
Qualifications:
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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