Study Startup Lead

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

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 and ensure that PSI clinical projects start smoothly and on time. 

Based in Ankara, Türkiye

 

You will:

• Lead all study startup activities/processes with local project teams
• Support activities in feasibility research and site identification process 
• Oversee electronic Trial Master File (eTMF) maintenance during startup phase 
• Coordinate activities on negotiation of site agreement and/or budget to ensure alignment to the site activation plan  
• Identify project-specific issues and escalate to all functions concerned as outlined in the Project Communication Plan 
• Supervise preparation and/or submission of the study dossiers to sites, to the competent authorities, IRBs/IECs, etc. 
• Review IP-Reds packages 
• Oversee and report on the site activation progress of the clinical sites 
• Monitor startup metrics and timelines
• Coordinate initiatives for startup process improvement, analyze best practices and challenges

• College/University degree or an equivalent combination of education, training and experience
• Minimum 3 years of industry experience in clinical research with practical 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
• Experience in mentoring and leadership is preferred

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.