Revenir à la liste des offres d'emplois Clinical Data Manager CDI · Ingénieur autre Bac+3 / Licence FIRALIS · HUNINGUE (France) A négocier Date de prise de poste : 15 avril 2022 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 ! Candidature Date limite : 31 mai 2022 Contacts Hélène SCHLIER caNOSPAMreers@firalis.com Offre publiée le 1 avril 2022, affichage jusqu'au 31 octobre 2022