Sponsor-Dedicated Start-Up Specialist

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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