Clinical Study Manager

vor 1 Woche

Wien, Österreich Valneva Vollzeit

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**:

- 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 required
- 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.

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