FSP - Sr. Regulatory and Start Up Specialist in Brazil

1 semana atrás

São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

Sao Paulo, Brazil | Full time | Home-based | R1518042

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
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