Job Overview
Under general supervision, perform tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include feasibility or maintenance activities.
The is a home-based position requiring regulatory experience. Proficiency in a Nordic language would be highly advantageous.
Essential Functions
Under general supervision, perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary.
Review documents for completeness, consistency and accuracy, under guidance of senior staff.
Prepare site documents, reviewing for completeness and accuracy.
Inform team members of completion of regulatory contractual. and other documents for individual sites.
Distribute completed documents to sites and internal project team members.
Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.
Qualifications
Bachelor's Degree Life science or related field Req
With 2 years’ experience in a healthcare environment or equivalent combination of education, training and experience. Established individual contributor who works under general supervision. Delivers objectives that significantly impact results for a job area. Tasks are not typically routine and may require applying discretion within broad operational boundaries and procedures. Problems faced are general and may require some analysis to resolve.
IQVIA 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 https://jobs.iqvia.com
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What We Do
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.
