Clinical Laboratory Scientist

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At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

CLINICAL LABORATORY SCIENTIST

We are recruiting 1 Clinical Laboratory Scientist to join us on a permanent position in Phoenix (Arizona, US).

YOUR MISSION

The Clinical Laboratory Scientist, reporting to the Department Leader, Design V&V and Clinical Operations will share responsibility for all aspects related to clinical sites including clinical study testing execution, study material management, monitoring of study completion and documentation achieving for a new medical instrument and associated device.

The primary objective of the Clinical Laboratory Scientist is to execute daily operations associated with clinical field studies required as part of the licensing and registration of the medical device instrument and consumable product in development by AliveDx.

More precisely, your main responsibilities will include:

• Help with the planning and management of assigned AliveDx clinical field studies.
• Support clinical field study development activities and strategies and assist on the execution of internal testing required for the completion of clinical field studies.
• Support on material request forms needed for the execution of internal studies.
• Manage the stock of investigational and non-investigational products.
• Be responsible for maintaining the sample biobank for clinical studies.
• Prepare study binders and clinical study forms required per clinical study.
• Assist on the documentation archiving process and maintenance of electronic Study Master File (eTMF).

YOUR COMPETENCIES

• A degree or relevant professional qualification in the related field.
• 2-5 years' experience in a clinical laboratory environment.
• Demonstrate ability to analyse information in a structured manner and to be able to prepare coherent technical reports.
• A working knowledge of GMP, ISO13485 and IVDR requirements.
• Team player and effective communication with a wide range of international customers, clinical study sites and external suppliers at all organisational levels.
• Effective time management and prioritisation skills, ability to self-motivate and great attention to detail with a thorough and methodical approach.
• Entrepreneurial spirit and ability to wear multiple hats as necessary.
• Ability to work under pressure, meet deadlines and respond flexibly.
• Ability to travel occasionally.

WHAT WE OFFER

• A highly dynamic and growing environment.
• An opportunity to live your passion for an intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
• A flexible working environment where applicable and a range of core and flexible benefits, ranging from lunch allowance support, additional annual leave, cycle to work scheme, technology and access to marketplace discounts.

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, religion/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.

As part of our recruitment process, an AI-pwered tool may be used to assist in the triage of applications. However, our HR team decides upon any selection or rejection.