Clinical Study Manager
November 7
Description
• We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. • We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world’s first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and Zika. • With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health. • Together, we are a global Company which is open to people of all backgrounds. Our diverse and inclusive workforce makes Valneva a great place to work. • Oversee all phases of clinical research, from feasibility and start-up to closeout • Manage roles and responsibilities of service providers, ensuring effective reporting, milestone tracking, deliverable management, and budget oversight • Conduct regular reviews of data metrics, including protocol deviations, eligibility and dosing violations, and serious non-compliance, to maintain high data quality • Ensure studies adhere to protocols, Valneva SOPs, Good Clinical Practice (GCP), and applicable regulatory requirements • Ensure all study activities align with project budgets, milestones, and timelines • Assist in sourcing Investigational Products as needed • 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
Requirements
• Academic education in Life Science, ideally in Sound Scientific (MSc.) • Minimum 5 years of experience in clinical operations or project management for Phase III/IV trials in the pharmaceutical/biotech industry • Experience in overseeing external service providers • Strong IT skills, including proficiency in Word, Excel, and PowerPoint • Strong organizational skills with the ability to manage multiple tasks • Ability to work in diverse interdisciplinary teams • Fluent in English; proficiency in Spanish or Portuguese is a plus • Willingness to travel, including long-distance trips
Benefits
• Open, appreciative company culture with innovative spirit and attractive assignments • International surrounding with flat hierarchies • Good team spirit in a strong and highly motivated team • Wide range of benefits like flexitime, compensation days, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events, myClubs, full access to LinkedIn Learning,...
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