Clinical Laboratory Scientist
About The Position
AliveDx is recruiting one Clinical Laboratory Scientist for a permanent position in Phoenix, Arizona. The role reports to the Department Leader, Design V&V and Clinical Operations, and shares responsibility for clinical-site activities, including clinical study testing, study-material management, monitoring study completion, and documentation for a medical instrument and associated device. The primary objective is to carry out daily operations for clinical field studies required for the licensing and registration of AliveDx’s medical device instrument and consumable product in development. The role supports study planning and development, internal testing, study-material requests, product and sample management, and study documentation and archiving.
Requirements
- A degree or relevant professional qualification in a related field.
- 2–5 years of experience in a clinical laboratory environment.
- Ability to analyse information in a structured manner and prepare coherent technical reports.
- Working knowledge of GMP, ISO 13485, and IVDR requirements.
- Ability to work as a team player and communicate effectively with international customers, clinical study sites, and external suppliers at all organisational levels.
- Effective time management and prioritisation skills, self-motivation, attention to detail, and a thorough and methodical approach.
- Entrepreneurial spirit and ability to take on multiple roles as necessary.
- Ability to work under pressure, meet deadlines, and respond flexibly.
- Ability to travel occasionally.
Responsibilities
- Help plan and manage assigned AliveDx clinical field studies.
- Support clinical field study development activities and strategies, and assist with internal testing required to complete clinical field studies.
- Support material request forms needed to execute internal studies.
- Manage stock of investigational and non-investigational products.
- Maintain the sample biobank for clinical studies.
- Prepare study binders and clinical study forms required for each clinical study.
- Assist with documentation archiving and maintenance of the electronic Study Master File (eTMF).
Benefits
- Lunch allowance support.
- Additional annual leave.
- Cycle-to-work scheme.
- Technology benefits.
- Access to marketplace discounts.
- Flexible working environment where applicable.
- A range of core and flexible benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
