Job Description

Job Responsibilities:Accountable for timely start-up activities from country allocation until site greenlight at assigned sitesConducts site selection visits, verifies site eligibility for a specific studyActs as the main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparationEnsures that milestones (KPIs) and time schedule for study start-up are met as plannedFacilitates the preparation and collection of site and country level documentsCollects submission-related site-specific documents for all relevant site personnel within agreed timelinesSupports the Site Activation Manager with preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
Supports the Site Activation Manager and assigned sites with vendor set-up activitiesPrepares and finalizes site specific documents for submissionNegotiates investigator payments, as neededSupports preparation of financial contracts between sponsor and investigational sites and investigators, as neededUpdates all systems on an ongoing basisSupports preparation of audits and inspections, as applicableSupports reduction of formal site-specific IRB/IEC deficienciesEnsures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readinessEnsures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirementsImplements innovative and efficient processes which are aligned with the sponsor\'s strategyJob Requirements:Min. 1 year of relevant experienceBachelor\xe2\x80\x99s Degree in life sciences or a related field and 3 years\xe2\x80\x99 clinical research or relevant experience in clinical start-up activitiesIn-depth knowledge of clinical systems, procedures, and corporate standards.Good negotiating and communication skills with ability to challenge, if applicable.Effective communication, organizational, and interpersonal skills.Ability to work independently and to effectively prioritize tasks.Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company\xe2\x80\x99s Corporate Standards.Understanding of regulated clinical trial environment and knowledge of drug development process.Ability to establish and maintain effective working relationships with coworkers, managers and clients#LI-HybridIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

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