Mots-Clés

Clinical Data Manager

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 an extreme quality environment (ISO 9001, ISO 13845, ISO 17025 and NF S 96-900), 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 R&D programs within our company, we are looking for a:

CLINICAL DATA MANAGER (W/M/D)

Job description

Under the responsibility of the Head of IT & Bioinformatic, your main missions are to:

• Monitor clinical data, review and manage discrepancies and data extractions
• Code clinical data in WHODrug and MedDRA for in-house clinical studies
• Program clinical data to ensure conformity with CDISC
• Develop, validate and manage the maintenance of in-house databases
• Harmonize clinical study data on a central database
• Review study data and generate description reports
• Prepare datasets for analysis
• Participate in the development of automation methods and technologies for data quality control
• Collaborate with the appropriate project team to resolve data issues
• Write, revise and improve Data Management documents and SOPs

Your profile

• Minimum Bac +3 (BSc, MSc, PhD) in related field preferred, or equivalent experience
• Relevant clinical Data Management experience in pharmaceutical industry, CROs or academic institutions
• Knowledge of clinical research and life sciences
• Working knowledge of CDISC/SDTM (candidate without CDISC programming experience should have interest in undergoing training)
• Strong competency with programming languages (R, Python…)
• Strong experience with relational databases (MySQL and PostgreSQL)
• Understanding of GCP and GDPR
• Fluent in French and English, writing and speaking skills
• Well trained in MS office programs: Word, Excel, PowerPoint
• Soft skills: Autonomy, teamwork, interpersonal skills

Do you want to join a dynamic human-sized company in which you will be involved on different innovative subjects? Don’t hesitate and send us your CV and cover letter !