Global Clinical Operations Manager
vor 1 Monat
Global Clinical Operations Manager
Job Summary:We are seeking a highly skilled Global Clinical Operations Manager to oversee all phases of clinical research, from feasibility and start-up to closeout.
Key Responsibilities:- 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.
- 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.
- 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.
- 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,...
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