Sponsor-Dedicated Start-Up Specialist in Türkiye

Fortrea; Fatih; On-site; TRY 120,000 - 180,000; Full time

Job summary

Fortrea is seeking a Start-Up Specialist to join our sponsor-dedicated team in Türkiye, based in Istanbul, to drive site activation and regulatory submissions for clinical studies.

You will oversee SSU activities from site list receipt to activation, manage ICF negotiations, IRB submissions, IMP release, and essential document templates, while contributing to strategic SSU planning and global study start-up processes.

Qualifications

• BS/BA degree or Associate 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.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.

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

Skills

Interpersonal skills

Written communication

Verbal communication

Administrative skills

Computer literacy

Clinical trial knowledge

Education

BS/BA degree

Associates degree

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
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.

Bringing life-changing benefits to patients faster

Fortrea is a global leader in clinical development and patient access solutions, empowering life sciences companies to accelerate innovative therapies from research to patient care.

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