Clinical Scientist - Huningue, France - FIRALIS GROUP

FIRALIS GROUP

Entreprise vérifiée

Huningue, France

il y a 1 semaine

Posté par:

Sophie Dupont

beBee Recruiter

Description

Firalis is a biotechnology company with a mission to improve disease outcomes, therapeutic decisions and generate savings in healthcare through biomarker discovery, development and regulatory qualification ultimately leading to biomarker-based diagnostics.

With a strong expertise and a high-quality environment (ISO 9001, ISO 13845, ISO 17025 and NF S , Firalis manufactures RUO and IVD kits and provides a comprehensive range of biomarker services from research to clinical trials in key therapeutic areas. Located in Huningue, its head office includes more than 2000 m2 of R&D and production laboratories.

To strengthen the Regulatory Affairs and Clinical Operations team of our company, we are looking for a:

CLINICAL SCIENTIST (W/M)

Job Overview:

Key Responsibilities:

As a Clinical Scientist, your main missions will be to:

Participate in regulatory submissions for approval of IVD devices
Participate in the preparation of IVD device technical files and briefing books for regulatory approvals
Collaborate with R&D, production and quality teams to generate all regulatory documents related to labeling, packaging and marketing
Collaborate with R&D, production and quality teams to prepare IVD device instructions for use, analytical validation plan and reports
Participate and provide recommendations on the development, design, validation and production of new IVDs
Verify that the device development process complies with FDA and CLSI guidelines
Collaborate with crossfunctional teams to develop study protocols, CRFs, informed consent forms, SOPs, investigator brochures, monitoring plans and other study documents
Participate in obtaining startup and modification authorizations for clinical studies from competent authorities and ethics committees throughout the EU
Be in charge of clinical site management and monitoring
Control the veracity, quality and standardization of data
Write clinical study reports.

Your profile

PhD or equivalent degree in biology, biochemistry, biotechnology, or a related scientific field
Prior experience in clinical research and clinical trial design
Strong knowledge of regulatory requirements and GCP guidelines
Detailoriented with strong organizational skills
Excellent analytical and problemsolving skills.
Exceptional communication and presentation abilities.
Fluent written and spoken English and French
Experience in neurodegenerative or cardiovascular disease would be an asset
Proficiency in data analysis software and statistical tools (e.g., SAS, R, or Python) is a plus.

If you meet the above requirements, we would love to hear from you. Please submit your resume and cover letter for consideration.

Type d'emploi :
Temps plein, CDI

Salaire :
à partir de 35 000,00€ par an

Avantages:
- Épargne salariale