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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing central laboratory operations for clinical trials, ensuring compliance with ICH-GCP and FDA/EMA regulations while maintaining high standards of quality and operational efficiency. Proficient in budget tracking, sample logistics, and stakeholder collaboration.
Highest-signal resume keywords
Clinical Trial ManagementICH-GCP ComplianceBudget TrackingStakeholder CollaborationOperational Quality Assurance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ConductSample CollectionData Protection LawsTrial Timeline PlanningLaboratory OversightRisk ManagementAudit PreparationLogistics ManagementTrial-Specific TrainingVendor Selection
Soft Skills
Attention to DetailClear CommunicationIndependent Problem SolvingSelf-Organizing AbilitiesAbility to Manage Competing Priorities
Tools & Technologies
Clinical Trial ProtocolsLaboratory MaterialsComputer Skills
Industry Keywords
Phase 1–4 Clinical TrialsCentral Laboratory ServicesFDA RegulationsEMA RegulationsSOPs
About the role
Key responsibilities & impact- Manage central laboratory aspects of phase 1–4 clinical trials within Valneva Clinical Operations
- Manage sample collection and testing and collaborate with internal and external stakeholders
- Ensure central-lab trial deliverables meet timelines, budget, operational procedures, and quality standards
- Ensure compliance with ICH-GCP, FDA/EMA regulations, other applicable regulations, and SOPs
- Serve as primary contact for internal and external parties regarding central laboratory services
- Contribute to central laboratory vendor selection and contracting
- Track and ensure accuracy of trial budgets, including forecasts and accruals
- Contribute to lab trial timeline planning and trial-specific training
- Set up central laboratory activities according to clinical trial protocols, including logistics, lab materials, aliquots, lab kits, and labels
- Oversee sample logistics from interim central storage facilities to central testing laboratories and Valneva’s Clinical Serology Department
- Support quality assurance activities and audit/inspection preparation
- Contribute to risk management and mitigation from trial setup through closeout
- Maintain oversight of laboratories, milestones, and trial-level data quality
- Provide operational backup across Central Lab Operations Group activities
Requirements
What you’ll need- Technical degree or Degree in natural sciences (BA, MSc); other equivalent combination of education, training and experience may be accepted in lieu of degree
- Minimum of 2 years of relevant experience in operational clinical research
- 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 clinical studies
- High self-organizing abilities
- Excellent computer skills
- Ability to manage multiple competing priorities and function independently
- Attention to detail
- Clear communication skills
- Independent problem solving
- Good knowledge of English, written and oral
- German is a plus
Benefits
Comp & perks- Dynamic and innovative work environment
- Open, appreciative company culture
- Impactful assignments
- Flat hierarchies
- International atmosphere
- Regular company events
- Flexitime
- Compensation days
- Performance-related bonus
- Lunch vouchers
- Free access to sports and fitness activities via myClubs
- Office massages