Job Description

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.

#LI-CB1

Learn more about our EEO & Accommodations request here.