The Senior Study Startup Specialist coordinates site activation activities, manages project-specific issues, and trains staff, ensuring successful study startup processes.
Company Description
PSI is a leading Contract Research Organization with more than 28 years 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- Coordinates study startup activities with the local project team and supports all processes critical for site activation.
- In the absence of stand-alone feasibility function, leads activities in feasibility research and site identification process.
- Facilitates site agreement and/or budget negotiations with sites to ensure alignment to the site activation plan.
- Leads site document collection for IRB/IEC submission and/or IP-RED process.
- Reviews study-specific translations.
- Identifies project-specific issues and escalates to Regional (Startup) Lead/PM and operational Manager in the country.
- Under supervision prepares and submits the study dossiers to investigators/institutions, competent authorities, IRBs/IECs.
- Ensures quality of IP-REDs packages.
- Ensures initial distribution of locally obtained clinical study supplies to sites and supervises initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites.
- Develops site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets under supervision.
- Provides startup-related training and methodological support to operational staff within the country/region.
- Provides on-the-job coaching of department staff.
- Supports preparation for audits on a country /regional level.
- Upon completion of the project startup phase, supports the preparation of a summary on operational challenges, best practices and lessons learned, and reports to Study Startup management and other functions concerned.
- University/college degree, or an equivalent combination of education, training, and experience
- At least 4 years’ experience in clinical research.
- At least 3 years of full-scope Study Startup experience
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.
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
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