Clinical Study Manager

3 weeks ago

Solna Municipality, Sweden Valneva Full time

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
  • 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
  • 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; proficiency in Spanish or Portuguese is a plus
  • Strong IT skills, including proficiency in Word, Excel, and PowerPoint
  • Willingness to travel, including long-distance trips
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:

  • Work Life Balance: flexitime & compensation days
  • Financial perks: Performance-related bonus & Lunch vouchers
  • Lifelong learning: Unlimited access to LinkedIn Learning & German/English courses for free
  • Health & Wellbeing: Free access to sports and fitness activities via myClubs and office massage

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

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Health Care Provider
  • Industries: Non-profit Organizations and Primary and Secondary Education
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