Regulatory And Start Up Specialist 2
hace 3 semanas
Job OverviewPerform tasks at a country level associated with Site Activation (SA) 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. Specialized in ICF.Essential FunctionsUnder general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions. Distribute completed documents to sites and internal project team members.Prepare site regulatory documents, reviewing for completeness and accuracy.Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.Review and provide feedback to management on site performance metrics.Review, establish, and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plans as needed.Inform team members of completion of regulatory and contractual documents for individual sites.Review, track, and follow up the progress, approval, and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.Provide local expertise to SAMs and project team during initial and ongoing project timeline planning.Perform quality control of documents provided by sites.May have direct contact with sponsors on specific initiatives.QualificationsBachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training, and experience.1 year experience in a leadership capacity. Equivalent combination of education, training, and experience.In-depth knowledge of clinical systems, procedures, and corporate standards.Ability to manage multiple projects.Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.Knowledge of applicable regulatory requirements, including local regulations, SOPs, and company’s 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.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.
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España Ergomed A tiempo completo(Senior) Specialist Regulatory Affairs/Start-upErgomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia.Our company allows for...
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(Senior) Specialist Regulatory Affairs/Start-up
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España Ergomed A tiempo completoCompany DescriptionErgomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia.Our company allows for employee visibility (you...
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Regulatory and Start Up Specialist 2
hace 2 meses
España IQVIA A tiempo completoJob Overview Perform tasks at a country level associated with Site Activation (SA) 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. Specialized in ICF. Essential Functions Under general...
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