Requirements: English
Company: AliveDx
Region: Eysins , Vaud
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 platformsare 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.
We are seeking 2 Clinical Studies Technicians to join our Clinical Affairs Team for a 6-month temporary position in Eysins, Switzerland.
YOUR MISSION
The Clinical Studies Technician will share responsibility for all aspects related to clinical sites including clinical trial 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 Studies Technician is to execute daily operations associated with clinical field trials 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:
- Helping with the planning and management of assigned AliveDx clinical field trials.
- Support clinical field trial development activities and strategies and assist on the execution of internal testing required for the completion of clinical field trials.
- Support on material request forms needed for the execution of internal studies.
- Stock management of investigational and non-investigational products.
- Responsible of maintaining the sample biobank for clinical studies.
- Preparation of study binders and clinical study forms required per clinical trial.
- Assisting on the documentation archiving process and maintenance of electronic Trial Master File (eTMF).
- Responsible for any function not specifically assigned that leads to the success and growth of AliveDx.
- Perform any other duties as reasonably requested from the Head of Clinical Affairs to meet the company corporate goals.
- Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements.
YOUR COMPETENCIES
- A degree or relevant professional qualification in the related field.
- 2-5 years'' experience in a clinical laboratory environment.
- Ideally significant specialist knowledge of clinical affairs as applied to in vitro diagnostic medical devices and instrumentation and an understanding of the operation of a medical device manufacturing establishment.
- Demonstrate ability to analyse information in a structured manner and to be able to prepare coherent technical reports.
- A working knowledge of GMP, ISO 13485 and IVDR requirements.
- Team player and effective communication with a wide range of international customers, clinical trial 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.
- Fluent in English (written and spoken) and ideally in French.
- Ability to travel.
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.
Interested? We invite you to send your application, including your resume and any other relevant documents. We look forward to exploring your potential contributions to AliveDx.
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.
Route de Crassier 13 1262 Eysins
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