Vaga de Regulatory Specialist 1
1 vaga: | Publicada em 01/05
- A Combinar
Sobre a vaga
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
" 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
"
" 1 year clinical research experience. Equivalent combination of education,
training and experience.
"
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 at
https://jobs.iqvia.com