- Under 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 plan as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- 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, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
- 1 year clinical research experience. Equivalent combination of education, training and experience.
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há 1 semana
IQVIA Sao Paulo, BrasilUnder moderate supervision, the **Site Activation Specialist **executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. · Prepares and manages s ...
Regulatory Specialist 1 - São Paulo, Brasil - Iqvia Llc
Descrição
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.Essential Functions
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.
Learn more atAbout UsIQVIA 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.#J-18808-Ljbffr
Usuários da profissão Regulatory Specialist 1 em São Paulo
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Elvis Oliveira
Group Product Manager | Head de Produtos
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Marco Custódio
Administrador / Gestor
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Rogério Eduardo Ferreira Soares
Administrador e Especialista em TI