FSP - Sr. Regulatory and Start Up Specialist in Brazil

BZL IQVIA RDS Brasil Ltda; São Paulo; Presencial; BRL 60.000 - 80.000; Tempo integral

Resumo da oferta

A leading global healthcare intelligence provider seeks a Site Activation Manager in São Paulo, Brazil. The successful candidate will manage site activation activities, ensuring compliance with guidelines and overseeing the preparation of regulatory documents. A Bachelor's degree in Health Sciences and over 3 years of relevant experience is required, along with advanced English skills. The role involves coordination with internal teams and stakeholders to ensure project timelines are met and deliverables are achieved.

Qualificações

• Bachelor's degree in Health Sciences required.
• Over 3 years of experience in Site Activation/Regulatory department.
• Expertise in ICF customization and submission processes.

Responsabilidades

• Serve as SPOC for assigned studies and stakeholders.
• Perform start-up and site activation activities according to regulations.
• Prepare and review site regulatory documents.

Conhecimentos

ICF customization

Experience in working with local and central ethics committees

Collection of essential documents from sites

Preparation of initial DDCM & DEEC for ANVISA

Advanced English

Excel knowledge

Formação académica

Bachelor's degree in Health Sciences

Descrição da oferta de emprego

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.

Essential Functions

• 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.

Qualifications needed

• Bachelor's degree in Health Sciences
• +3 years of experience in the Site Activation/Regulatory department in:
  • ICF customization
  • Preparation and submission of studies in startups to local and central ethics committees
  • Collection of essential documents from the sites
  • Preparation of initial DDCM & DEEC for ANVISA
  • Experience in annual and final study reports
• Advanced level of English
• Excel knowledge

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