Regulatory & Start-Up Coordinator in Bucharest, Romania in Bucuresti

Job OverviewUnder general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or internationalregulations, 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:• 3 years’ experience in an administrative environment or equivalent combination of education, training and experience.•English language fluency requiredIQVIA 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.comIQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.EEO Minorities/Females/Protected Veterans/Disabled To help us track our recruitment effort, please indicate in your cover//motivation letter where (vacanciesinukraine.com) you saw this job posting.

Contact

Datele de contact vor fi vizibile dupa ce veti aplica!

loading...
www.mynextjob.ro folosește cookies. Navigând în continuare, iți exprimi acordul pentru folosirea acestora. Află mai multe Am ințeles!