Argentina Job Openings
IQVIA
FSP - Sr. Regulatory and Start Up Specialist in Argentina
FULL TIME
August 23, 2024
The Sr. Regulatory & Start Up Specialist will 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.
- 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
- Bachelor Degree in life sciences.
- +3 years of clinical research experience within regulatory area in Argentina:
- Local submissions
- ICF customization (site and country level)
- Presentations to ethics committee & ANMAT.
- Fluent English: written and oral communication skills
- Ability to work independently
#LI-Remote #LI-NRJ
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
New Job Alerts
BRAVIUM LATAM
Analista de Excelencia Operacional
Buenos Aires
FULL TIME
November 18, 2024
View Job Description
Looking for similar job?
Roche
Regulatory Affairs Specialist - Medical Devices
Buenos Aires
FULL TIME
September 13, 2024
View Job Description
IQVIA
Associate Manager, Regulatory Start Up (External Commerce LATAM)
Buenos Aires
FULL TIME
September 17, 2024
View Job Description
S&P Global
Senior Operations Analyst- Regulatory Reporting
Buenos Aires
August 24, 2024
View Job Description
See What’s New: IQVIA Job Opportunities
IQVIA
Site Activation Coordinator in Brazil
São Paulo
FULL TIME
November 5, 2024
View Job Description
IQVIA
Site Research Assistant: Maceió, Brazil (Fix Term and Part time)
PART TIME
November 2, 2024
View Job Description
IQVIA
Research Coordinator in Fortaleza, Ceará, Brazil (Fixed-Term & Part-time)
PART TIME
October 25, 2024
View Job Description
IQVIA
Medical Science Liaison - Oncology - Brazil
São Paulo
FULL TIME
October 9, 2024
View Job Description
New Job Alerts
BRAVIUM LATAM
Analista de Excelencia Operacional
Buenos Aires
FULL TIME
November 18, 2024
View Job Description