Sponsor-Dedicated Start-Up Specialist in Türkiye

•  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

• 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