Are you looking for the next challenge in your career?
Would you like to be part of an exciting highly qualified team of professionals in an international environment?
We are currently looking for a Clinical Data Management Join an international division and work alongside with some of the most talented engineers and technicians from all over the world.
Your benefits: Competitive Salary.
Long-term secure contract.
International Project with top technologies Possibility of working remotely with a flexible schedule.
Integration in a highly qualified team of professionals.
Travel abroad with your project.
Specialized training and continuous professional development.
Social benefits and flexible compensation plan.
Qualifications and Experience: In addition to our current use of SAS for data analysis and submission, we are seeking an R specialist to develop equivalent capabilities using R for data analysis and submission.
Education in Mathematics, Statistics, Computer Science, or Data Science Experience in data analysis, statistical modeling and development using R Familiar with clinical data standards such as CDISC SDTM and ADaM Experience in R package management (local and global) and configuration Experience in submission to regulatory authorities with R is a plus Capability to develop written procedures to support processes Understanding of regulatory requirements and guidelines (e.g., FDA, EMA, ICH-GCP) CDMS experience is a plus Ability to work collaboratively with cross-functional teams We seek a Validation Engineer to help update QMS documentation (risk assessment, traceability matrix, update of SOP/WKI) and assist with project validation activities due to the application change.
Experience in software validation in the clinical domain Strong documentation skills for creating risk assessment, traceability matrix and SOP/WKI update.
Understanding of regulatory requirements and guidelines (e.g., FDA, EMA, ICH-GCP) CDMS experience is a plus Meticulous attention to detail to ensure all aspects of the system are thoroughly validated Excellent communication skills to interact with stakeholders and document validation activities Ability to work collaboratively with cross-functional teams We positively value all work or study experience abroad.
All positions require a high level of English (at least B2) - please send your detailed CV in English.