Job Overview
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.
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
• Bachelor's Degree in life sciences.
• +3 years of clinical research experience within regulatory area in Argentina:
Local submissions
ICF customization
Presentations to ethics committee & ANMAT.
• Fluent English: written and oral communication skills
• Ability to work independently
As part of the recruitment process, selected candidates may be subject to background checks that are relevant and proportionate to the role. These checks will be conducted with the candidate’s prior consent, and in compliance with applicable data protection and labor regulations.
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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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Skills Required
- Bachelor's Degree in life sciences
- 3+ years of clinical research experience within regulatory area
- Experience with local submissions, ICF customization, and presentations to ethics committee & ANMAT
- Fluent in English, written and oral skills
- Ability to work independently
IQVIA Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about IQVIA and has not been reviewed or approved by IQVIA.
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Healthcare Strength — Healthcare coverage is positioned as comprehensive, spanning medical/dental/vision plus programs like telemedicine, EAP resources, and additional insurance options. Feedback suggests the health offering is a meaningful part of the overall rewards package, though details can vary by location and plan design.
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Retirement Support — Retirement benefits include an employer match structure that supports employee contributions through a defined formula. This adds steady long-term value to total rewards beyond base salary.
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Leave & Time Off Breadth — Time off offerings include vacation/paid time off, holidays, and flexibility themes, with some roles described as having discretionary or unlimited time-off models. This can make the package feel more attractive even when cash compensation is viewed as only mid-range.
IQVIA Insights
What We Do
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.
