Senior Study Startup Specialist

PSI CRO; Çankaya; Hybrid; TRY 1,229,000 - 1,967,000; Full time

Job summary

A leading Contract Research Organization in Turkey is seeking a Study Startup Specialist to support clinical projects and ensure smooth project initiation. Candidates should have at least 4 years of clinical research experience and expertise in local regulations. This position allows for office-based or remote work, focusing on quality service delivery in a dynamic environment.

Qualifications

• College/University degree or equivalent combination of education, training and experience.
• At least 4 years of experience in clinical research.
• At least 3 years of full-scope Study Startup experience in Türkiye.
• Excellent knowledge of ICH GCP, local laws and applicable regulations in the region.
• Full working proficiency in English and Turkish.
• Communication and organizational skills.
• Ability to negotiate and build relationships at all levels.

Responsibilities

• 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.
• Identify project-specific issues and escalate to Regional (Startup) Lead/PM.

Job description

PSI is a leading Contract Research Organization with 30 years experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

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

• Performstudy startup activities and supportall processes critical for site activation.
• Collectsite documents for IRB/IEC submission and/or IP-RED process.
• Filestudy-specific documentation in TMF, in accordance with Document management plan.
• CompileIP-REDs packages assuring high quality.
• Reviewstudy-specific translations, including patient-facing documents.
• Supportsite agreement and/or budget negotiations, upon request.
• Ensureinitial distribution of locally obtained clinical study supplies to sites and superviseinitial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites.
• Identifyproject-specific issues and escalates to Regional (Startup) Lead/PM and operational Manager in the country.
• Developsite-specific startup timelines and is responsible for meeting the site activation targets under supervision.

Qualifications

• College/University degree or an equivalent combination of education, training and experience
• At least 4 years' experiencein clinical research
• At least 3 years of full-scope Study Startup experience in Türkiye
• Excellent knowledge of ICH GCP, local laws and applicable regulations in the region
• Full working proficiency in English and Turkish
• Communication and organizational skills
• Ability to negotiate and build relationships at all levels

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.