Study Start up Specialist, IQVIA Biotech

IQVIA; São Paulo; On-site; BRL 90,000 - 140,000; Full time

Job summary

IQVIA is seeking a Site Activation professional in São Paulo, Brazil, to perform country-level activation tasks and maintain regulatory documents in compliance with SOPs and project timelines. You will act as the SPOC for sites and coordination with SAMs and the PM team, ensuring accurate regulatory submissions and tracking.

Experience with US/Canada ICF reviews is required, with preference for adapting country ICFs to regulatory requirements.

Qualifications

• 1 year clinical research experience.
• Site activation US & CAN ICF review experience required.
• Experience adapting country ICF for US/Canada regulatory requirements.
• Experience reviewing consent forms using site ICF and central IRB checklists.

Responsibilities

• Serve as SPOC for investigative sites and project teams.
• Perform site activation activities per SOPs and regulations.
• Prepare regulatory documents and maintain trackers.
• Review site performance metrics and timelines.

Skills

Clinical research

Site activation

Regulatory documentation

Job description

São Paulo, Brazil

Full time

R1574813

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.

Site activation US and CAN ICF review experience is required.

Experience in adapting a country ICF for US and Canada regulatory requirements is preferred, but not required.

Experience reviewing information consents for elements of consent using a checklist, site specific ICF and central IRB ICFs. Both site activation ICF and for revised ICF in study maintenance

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.

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 is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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