Central Lab 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 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.

REQUIREMENTS

• Technical degree or Degree in natural sciences (BA, MSc, …) - other equivalent combination of education, training and experience may be accepted in lieu of degree
• A minimum of 2 years of relevant experience in operational clinical research, and a minimum of 1 year of management experience in clinical trial conduct
• Good knowledge of ICH-GCP, data protection laws, clinical trial directives and other regulations and guidelines for the conduct of clinical studies
• High self-organizing abilities, proactive and excellent computer skills
• Ability to manage multiple competing priorities, function independently and attention to detail
• Clear communication skills and independent problem solving
• Good knowledge of English (written and oral), German as a plus

The Central Lab Operations Manager manages central laboratory aspects of phase 1-4 clinical trials within Valneva Clinical Operations. Besides central management of samples collection and testing, he/she is accountable for collaboration with Valneva internal and external stakeholders to deliver related business objectives. She/he ensures operational trial deliverables related to central lab are met according to timelines, budget, operational procedures and quality standards. The Central Lab Operations Manager ensures compliance with ICH-GCP, FDA/EMA regulations, other regulations and SOPs, as applicable.

Your responsibilities will include:

• Supporting and backing-up the Central Lab Operations Lead in all aspects of the Central Lab Operations Group
• Acting as a contact person for internal and external parties regarding central laboratory services of assigned clinical trials, follows up and responds to clinical trial specific inquiries
• Contributing to Central Lab vendor selection and contracting
• Tracking and ensuring accuracy of trial budgets, including forecast and accruals information
• Contributing to detailed planning of Lab trial timelines and to trial specific training for internal and/or external team members
• Setting-up Central Lab activities according to the clinical trial protocol (logistics operations, definition of lab materials, aliquots and lab kits incl. labels)
• Overseeing and managing sample logistics from interim central storage facility to central testing labs/Valneva´s Clinical Serology Department
• Contributing to Quality Assurance activities, supporting audit/inspection preparation
• Reviewing Risk management/risk mitigation plan from trial set-up until trial close-out
• Keeping comprehensive oversight of the laboratories involved, milestones achieved, and the data quality provided at the trial level