Central Lab Operations Specialist (part-time, 20 hours/week)
Valneva, Austria
Job Description
The Central Lab Operations Specialist is managing within this this part-time position (20 hours/week) central laboratory aspects of phase 1-4 clinical studies within Valneva Clinical Operations. He/she will contribute in ensuring operational study deliverables related to central lab are met according to timelines, budget, operational procedures and quality standards. The Central Lab Operations Specialist ensures compliance with ICH-GCP, FDA / EMA regulations, other regulations and SOPs, as applicable.
Responsibilities
- Contributes to Central Lab vendor selection
- Contributes to detailed planning of Lab study timelines
- Tracks and ensures accuracy of study budgets, including the forecast and accruals information
- Contributes to study specific training for internal and/or external team member
- Maintains documentation and tracker (kit shipment/ samples shipment/ sample storage/)
- Follows-up on development of lab manual in the course of the study
- Contributes to Quality Assurance activities including support of development and revision of SOPs, support audit / inspection preparation, conduct and follow-up;
- Reviews Risk management/ risk mitigation plan in the course of the study until study close-out
Requirements
- Technical degree or Degree in natural sciences (BA).
- Other Equivalent combination of education, training and experience may be accepted in lieu of degree.
- A minimum of 2 years of relevant experience in clinical research.
- Good knowledge of ICH-GCP, data protection laws, clinical trial directives and other regulations and guidelines for the conduct of clinical studies.
- Experience in clinical laboratory samples handling.
- Strong organizational skills.
- Clear communication skills and independent problem solving.
- Ability to manage multiple competing priorities, function independently and attention to detail.
- Good knowledge of English (written and oral).
- Good computer skills
Benefits
- Open, appreciative company culture with innovative spirit and attractive assignments
- International surrounding with flat hierarchies
- Good team spirit in a strong and highly motivated team
- Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (Kindergarten), company events
Due to legal reasons we are obliged to disclose the minimum salary for this position, which is 33.000,00 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.