Study Start up Specialist, IQVIA Biotech

5PY IQVIA RDS Inc.; São Paulo; On-site; BRL 60,000 - 100,000; Full time

Job summary

IQVIA is seeking a Site Activation professional to manage country-level activities, ensuring regulatory and contractual timelines are met. You will coordinate with investigative sites, SAMs, and the project team, performing start-up tasks, preparing regulatory documents, and maintaining data integrity across systems.

The role requires strong regulatory knowledge, experience with ICF review, and the ability to work under supervision while delivering quality deliverables.

Qualifications

• 1 year clinical research experience or equivalent combination of education, training and experience.
• Site activation ICF review experience for US and Canada is required.
• Experience adapting country ICF for US/Canada regulatory requirements preferred.
• Experience reviewing information consents for elements of consent using a checklist, site ICF and central IRB ICFs.
• Experience in site activation ICF and revised ICF in study maintenance.

Responsibilities

• Serve as single point of contact for investigative sites, SAM, PM team and other departments.
• Perform startup and site activation activities per regulations and SOPs.
• Prepare site regulatory documents and review for completeness.
• Maintain internal systems and project information accurately.
• Provide feedback on site performance metrics to management.
• Plan project timelines and ensure contingency measures.

Skills

Clinical research experience

SPOC responsibilities

Regulatory knowledge

ICF/consent review

Project coordination

Job description

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

About IQVIA

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.