Central Lab Operations Manager (m/f/d)

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.

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, she/he 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:

• →Serving as primary contact for internal and external parties regarding central laboratory services for assigned clinical trials, follows up and responds to clinical trial-related 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
• →Contributing to 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
• →Supporting and providing operational back-up across all activities within the Central Lab Operations Group

• 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