Study Startup Specialist II

Benefits

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Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time. This is an office-based position from our Bangalore office . You will: Collaborate with the project team for site activation processes Facilitate site agreement, contract negotiations and budget negotiations Collect site documents for IRB/IEC submission and/or IP-RED process Coordinate translation and review of study-specific documents Identify and escalate project-specific issues as needed Prepare and submit the study dossiers to sites, competent authorities, IRBs/IECs Prepare IP-REDs packages Support initial distribution of Investigational Product(s) and clinical study supplies to sites Ensure exchange of information and documentation with investigational sites, off site facilities and vendors Participate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets College/University degree in Life Sciences or an equivalent combination of education, training and experience At least 2 years of full-scope Study Startup experience in India-based trials Full professional working proficiency in English Well-developed communication and organizational skills Ability to negotiate and build relationships at all levels

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