Senior Study Startup Specialist
Full-time Mid-Senior LevelJob Overview
Take your career to the next level and be involved in study startup processes in Türkiye. You will provide direct operational support to project teams, ensure that clinical projects start smoothly and on time and support PSI in developing the local study startup team.
Office-based in Ankara or remote
- Perform study startup activities and support all processes critical for site activation.
- Collect site documents for IRB/IEC submission and/or IP-RED process.
- File study-specific documentation in TMF, in accordance with Document management plan.
- Compile IP-REDs packages assuring high quality.
- Review study-specific translations, including patient-facing documents.
- Support site agreement and/or budget negotiations, upon request.
- Ensure initial distribution of locally obtained clinical study supplies to sites and supervise initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites.
- Identify project-specific issues and escalates to Regional (Startup) Lead/PM and operational Manager in the country.
- Develop site-specific startup timelines and is responsible for meeting the site activation targets under supervision.
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