Senior Study Startup Specialist

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.

• 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​

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