Offer summary

Qualifications:

College/University degree or equivalent education and experience, Minimum 3 years of industry experience in clinical research with startup experience in Türkiye, Excellent knowledge of ICH GCP and local regulations, Full working proficiency in English and Turkish, with strong communication and organizational skills..

Key responsibilities:

Lead all study startup activities with local project teams

Support feasibility research and site identification processes

Oversee eTMF maintenance during the startup phase

Monitor startup metrics and coordinate process improvement initiatives.

Job description

Company Description

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.

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.

Home-based or office-based

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

Qualifications

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

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.

Required profile