- Location
- Vienna, Vienna, Austria · published
- Type
- Full-time
- Department
- Operations
- Seniority
- Manager
- Source
- Workable
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