Site Activation Specialist

IQVIA LLC; São Paulo; Híbrido; BRL 120 000 - 180 000; Tempo integral

Resumo da oferta

IQVIA, a global leader in clinical research services, seeks a site activation professional to drive feasibility studies and regulatory activities across regions, coordinating with SAM and cross-functional teams to ensure timely start-up and compliant site documentation.

Key responsibilities include managing site contracts, reviewing documents for accuracy, and maintaining project timelines while adhering to SOPs and regulatory guidelines.

Qualificações

• Bachelor's Degree Life sciences or related field is required.
• 1-3 years’ clinical research or equivalent experience.
• 3 years’ healthcare environment experience or equivalent.

Responsabilidades

• Serve as SPOC for feasibility, site activation and maintenance activities in assigned studies, ensuring regulatory compliance and timelines.
• Review and prepare site documents, ensuring completeness and accuracy.
• Track and communicate completion of regulatory and site documents to internal teams and sites.

Formação académica

Bachelor's Degree Life sciences or related field

Descrição da oferta de emprego

Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines. With moderate oversight and supervision, perform tasks at a country/region level associated with site activation 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

• With moderate oversight and supervision, werve a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
• Prepare site documents, reviewing for completeness and accuracy.
• Inform team members of completion of regulatory contractual. and other documents for individual sites.
• Distribute completed documents to sites and internal project team members.
• Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
• Review, track and follow up the progress, the approval and execution of required documents such as questionaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.

Qualifications

• Bachelor's Degree Life sciences or a related field Req And
• Other 1 - 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience. Req
• With 3 years’ experience in a healthcare environment or equivalent combination of education, training and experience.

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.