Clinical Data Coordinator

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 COORDINATOR (W/M)**

**Job description**

Under the responsibility of the Head of Clinical Operations and Data Management, your main missions will be 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 in-house 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

**What we offer**:

- The possibility to join a dynamic human-sized company and be involved in various innovative projects
- Flexible hours
- Employee and pension savings plans
- Sustainable mobility bonus (bicycle/carpooling)
- Incentive bonus based on the group's financial performance
- Opportunities for advancement
- Office snacks

If you’re interested, then don’t hesitate and send your CV and cover letter

**Job Types**: Full-time, Permanent

**Salary**: From 35,000.00€ per year

**Education**:

- Bachelor's (required)

**Experience**:

- Clinical data management: 1 year (required)

Work Location: Hybrid remote in 68330 Huningue