Fixed-term employment contract (18 months)
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.
Responsibilities
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
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
Benefits
Working with Valneva means being part of a global biotech company with a clear vision to make a meaningful impact in the world. At Valneva, you can expect a dynamic and innovative work environment characterized by an open, appreciative company culture and exciting, impactful assignments. Enjoy the benefits of flat hierarchies, an international atmosphere, and regular company events that foster collaboration and connection.
Additionally, we offer:
- Work Life Balance: Flexitime & Compensation days
- Financial perks: Performance-related bonus & Lunch vouchers
- Health & Wellbeing: Free access to sports and fitness activities via myClubs & Office Massages
Join us and shape the future of biotechnology!
Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 44.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.