Job Overview
Under general supervision, perform tasks at a country level associated with contracts or start up (LEC-CEC submissions) for 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 maintenance activities.
Essential Functions
• Under general supervision, perform site activation 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 regulatory documents, reviewing for completeness and accuracy.
• Inform team members of completion of regulatory and contractual 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 documents, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.
Qualifications
• Bachelor's degree
• With 1-3 years’ experience in a similar position in a healthcare environment (site, CRO, pharma).
• At least 1 years managing contracts or managing start up submissions
• Good interpersonal communication and organizational skills.
• Advanced level of English
#LI-NRJ #Hybrid role
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
