Clinical Study Manager

vor 4 Wochen

Wien, Wien, Österreich Valneva Vollzeit
Job Title: Clinical Study Manager

We are a leading vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.

Our team has leveraged our expertise and capabilities 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 multiple countries, we are committed to making a positive impact on global public health.

We are a global company that values diversity and inclusion, and our workforce reflects this commitment.

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
  • 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,...

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

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