Central Lab Operations Manager (m/f/d)

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.