Study Startup Lead
Study Startup Lead
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Job Description
Take your career to the next level and be involved in study startup processes in Trkiye. 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 Trkiye
- 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.
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
