Central Lab Operations Manager (m/f/d)

Valneva; Wien; On-site; EUR 40,000 - 48,000; Full time

Benefits offered by this job

Work-Life Balance: Flexitime/Comp days

Performance bonus & Lunch vouchers

Health & Wellbeing: Office Massages

Job summary

Valneva SE in Vienna is seeking a Central Lab Operations Manager for an 18-month fixed-term role in clinical operations. You will lead central lab activities for Phase 1-4 trials, ensure compliance with ICH-GCP and regulatory guidelines, and collaborate with internal and external stakeholders to meet trial objectives.

You will manage timelines, budgets, vendor relations, and training while ensuring data quality and operational efficiency. English proficiency is required; German is a plus.

Qualifications

• Degree in natural sciences or equivalent
• Minimum 2 years in operational clinical research and 1 year in trial management
• Knowledge of ICH-GCP, data protection laws, and clinical trial directives/regulations
• Strong organizational and computer skills; ability to manage multiple priorities
• Clear communication and independent problem solving
• Good knowledge of English; German is a plus

Responsibilities

• Serve as primary contact for central lab services in assigned trials
• Contribute to Central Lab vendor selection and contracting
• Track trial budgets, forecasts and accruals
• Plan Lab trial timelines and training for teams
• Set up Central Lab activities per protocol and materials labeling
• Oversee sample logistics from storage to testing labs
• Support QA activities and audit/inspection prep
• Contribute to risk management from setup to close-out
• Maintain oversight of labs, milestones, and data quality
• Provide operational backup across Central Lab operations

Skills

Clinical operations

Team leadership

ICH-GCP knowledge

English proficiency

Problem solving

Education

Technical degree or natural sciences degree (BA/MSc)

Job description

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

• 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

Working with Valneva means being part of aglobal biotech companywith a clear vision to make a meaningfulimpact in the world. At Valneva, you can expect a dynamic andinnovativework environment characterized by an open, appreciative company culture and exciting,impactful assignments. Enjoy the benefits offlat hierarchies, an international atmosphere, and regular company events that fostercollaborationand 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.