Clinical Study Manager (m / f / d)

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.

Responsibilities

• 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

Benefits

Working at Valneva offers the opportunity to be part of a global biotech company with a strong vision for making a positive impact. The company fosters an open, appreciative culture with an  innovative mindset  and provides engaging assignments. It also offers an international environment with  flat hierarchies  and regular  company events .

You can expect the following benefits :

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 60.000,00 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.