Clinical Operations Manager (m/f/d)

at  Valneva

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, Shigella and Zika.

REQUIREMENTS

• Academic education, Master or PhD degree in Life Science
• Minimum of 3 years of clinical management experience including at least 2 years with global/regional overall study responsibilities (Global/Regional Study Manager or similar)
• Profound knowledge of ICH-GCP, data protection laws, clinical trial directive and other regulations and guidelines relevant for the conduct of clinical trials
• Ideally experience in the field of vaccine development
• Supervisory/managerial experience in clinical development including supervision of CROs is a must
• Excellent communication, presentation, interpersonal, independent problem solving, financial management and leadership skills
• Organized and independent work style with strong systematic approach to prioritization but still detail oriented
• Excellent command of English (spoken and written) and excellent computer skills

• Responsible for all aspects of one or more phase 1-4 clinical studies from protocol review through interim analysis until clinical study report finalization for regulatory submission
• Ensures compliance with ICH-GCP and FDA/EMA regulations, other regulations, and SOPs, as applicable
• Ensures all operational study deliverables are met according to timelines, budget, operational procedures, and quality standards
• Manages CROs and other external partners and ensures adherence to scope of work within timelines and budget
• Interacts with other departments and relevant functional areas
• May be required to travel to supervise and coordinate clinical studies