Job Description

Site Activation Specialist (RA expert)

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Seoul, South Korea Full time R1416950

Seoul, South Korea| South Korea

Job description

Job Overview
Manage and lead activities associated with Feasibility and/or Site Identification for regional and/or country projects and/or programs.

Essential Functions
Manage assigned opportunities/projects/programs for country or region and adhere to timelines and budget. Ensure the site list for assigned studies includes an adequate number of appropriate investigators in accordance with the needs of the sponsor and specifications of the protocol. Collect and analyze country/regional Feasibility and/or Site Identification information to meet timelines of each study. Attend kick off meeting to understand study requirements include investigator profile, protocol, process specifics and timelines. Raise questions and make suggestions based on SID SOPs and Work Instructions. Distribute, track, negotiate and review the Confidential Disclosure Agreements (CDAs) for Feasibility and/or Site Identification with input from the study team, management and Legal when appropriate. Distribute, track and review Site Questionnaires for Feasibility and/or Site Information Forms or Site Qualification Questionnaires for SID . Ensure completeness, site capability and suitability for the study. For SID reviews SIF and/or SQQ vs the guidance document and approve for SSV or select appropriate sites. Manage investigator database entry and quality, ensuring complete investigator and site information is captured and monitor for duplicate entries. Maintain and update company information repositories and databases.

Qualifications

• IND submission to MFDS for approval and its maintenance, notification, label review for Phase 1-4 studies
• CRO/pharma 에서 IND 업무 경력자 지원 가능
• Global study 유경험자 선호
• Good English communication skill is required

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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