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 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.

Responsibilities

• 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

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 € ,- gross per year based on full-time employment. However, our salaries are market oriented and in line with your qualifications and experience.