A Clinical Data Programmer - 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 an extreme 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 R&D programs within our company, we are looking for a
:CLINICAL DATA PROGRAMMER (W/M)

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

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

Your profile

Minimum Bac +3 (BSc, MSc, PhD) in Life Sciences or any related field preferred, with similar work experience
Relevant clinical Data Programming experience in pharmaceutical industry, CROs or academic institutions
Working knowledge of CDISC/SDTM
Strong competency with programming languages (R, Python )
Strong experience with relational databases (MySQL and PostgreSQL)
Knowledge of clinical research and life sciences
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