Study Start up Specialist I

3 semanas atrás

São Paulo, São Paulo, Brasil IQVIA LLC Tempo inteiro

Study Start up Specialist I

Apply locations

São Paulo, Brazil

Time type

Full time

Posted on

Posted Yesterday

Job Requisition ID

R1500196

Job 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.

Essential Functions
  1. 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 SOPs, Work Instructions (WIs), quality of deliverables, and project timelines.
  2. Perform start-up and site activation activities according to regulations, SOPs, and work instructions. Distribute completed documents to sites and internal team members.
  3. Prepare site regulatory documents, reviewing for completeness and accuracy.
  4. Ensure accurate maintenance of internal systems, databases, and tracking tools with project-specific information.
  5. Review and provide feedback on site performance metrics.
  6. Review, establish, and agree on project planning and timelines. Implement monitoring measures and contingency plans as needed.
  7. Inform team members of regulatory and contractual document completion for sites.
  8. Track and follow up on document progress, approval, and execution, including regulatory, ethics, ICF, and Investigator Pack release documents, in line with timelines.
  9. Provide local expertise during initial and ongoing project planning.
  10. Perform quality control of documents provided by sites.
  11. May have direct contact with sponsors on specific initiatives.
Qualifications
  • 1 year of clinical research experience or equivalent education, training, and experience.

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

About Us

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do aims to improve patient outcomes and population health worldwide.

We seek diverse talent with curious minds and a relentless commitment to innovation and impact. Everyone at IQVIA contributes to our shared goal of helping customers improve patients' lives worldwide. Thank you for your interest in growing your career with us.

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