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Senior Study Startup Specialist
6 days agoWhat's your preference?
Job Description
- Req#: 744000068494967
- 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
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.
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