We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.

REQUIREMENTS

• Completed Master’s Degree in Life Science or equivalent combination of education and work experience in clinical trials
• At least 5 years of experience as a Clinical Project Manager (CPM) and/or as Clinical Research Associate (CRA) at a CRO/medical device or pharmaceutical company, ideally for Phase III/IV trials
• Experience in overseeing external service providers
• Experienced in working in Clinical Research with LATAM, specifically Brazil is a plus
• Strong organizational skills with the ability to manage multiple tasks and work in diverse interdisciplinary teams
• Fluent in English; high level of Portuguese is a must; fluency in Spanish is a plus
• Strong IT skills, including proficiency in Word, Excel, and PowerPoint
• Willingness to travel, including long-distance trips

• Oversight of several clinical studies regulated by the FDA and EMA
• Management and execution of clinical research tasks related to the lifecycle of the studies, from feasibility and start-up to close out
• Manage roles and responsibilities of service providers, ensuring effective reporting, milestone tracking, deliverable management, and budget oversight
• Contribute to the development of core study documents based on scientific evidence, clinical research knowledge and in alignment with study/program objectives
• Ensure data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
• Make sure studies comply with protocols, Valneva SOPs, Good Clinical Practice (GCP), and relevant regulatory requirements
• Ensure that all study activities align with the project’s budget, milestones, and timelines
• Collaborate with Valneva stakeholders to monitor budgets and financial agreements, facilitating timely reporting to funding organizations and payments
• Participate in the preparation of annual reports for funding organizations
• Contribute to quality assurance activities, including the development and revision of SOPs and support for audit and inspection preparation
• Travel to study sites as required to support study execution