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Study Start Up Associate, (Europe, homebased) – IQVIA Biotech

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Primary Location: Stevenage, United Kingdom Additonal Locations: Barcelona, Spain,ESP; Bratislava, Slovakia,SVK; Bucharest, Romania,ROU; Budapest, Hungary,HUN; Milan, Italy,ITA; Paris, France,FRA; Prague, Czech Republic,CZE; Riga, Latvia,LVA; Warsaw, Poland,POL Full time R1220970

Job description

Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials and Essential Documents (ED) during the start-up period of the study. Work with both internal and external teams to assure good communication, regarding start-up activity. Assure documents maintained for start-up of a study are in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP) and country specific procedures set forth by IQVIA Biotech and its clients. A Study Start-up Associate I will work in conjunction with or under the supervision of a more senior SSU Associate or members of the study start up team.


• Supports the SSU Manager or SSU Lead to provide updates during weekly client teleconferences and internal team meetings, as required.
• May Assist in the dissemination of Confidential Disclosure Agreements (CDAs) and feasibility questionnaires to sites and follows up with sites accordingly to ascertain interest and to meet study timelines.
• May participate in the review and negotiation of the CDAs according to country specific requirements.
• Support the SSU team as required to send regulatory packets/documents to selected sites and/or follows-up with sites on the start-up process at the site.
• Support the SSU team as required to collect essential regulatory documents required to activate a site according to the study specific Essential Regulatory Document Checklist.
• Compiles and completes a review of these regulatory documents into a complete “green light package” (GLP), performing a final review prior to submission for final sign-off.
• Once GLP is complete, submits for final sign-off and works with the final reviewer and SSU team to resolve any findings and/or queries.
• Responsible for transitioning sites from SSU to Site File Operations representative
• Adheres to study timelines, documents/escalates study challenges, and communicates updates to SSU Manager and/or SSU Lead and/or Line/Study Management.
• Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) for the study.


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

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