Application Developer Clinical and Quality Systems
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Application Developer Clinical and Quality Systems for a permanent position based in Basel area.
The ideal candidate should have 2 – 3 years of previous experience, solid knowledge of Java, CSV and GxP would be preferable.
The Application Developer is responsible for developing, administering and maintaining data analytics, and integration applications or platforms, based on user, process and functional requirements. He/she will work in the Clinical Development and Quality Management area and needs a solid understanding of GxP regulations and CSV requirements.
- Capture and elaborate user/process requirements in close cooperation with business functions in CSV or GxP compliant documentation;
- Analyze business requirements and develop user friendly data analytics applications, mainly in Qlik Sense;
- Integrate, transform and model source data within the Clinical Development and Quality Management space to display visuals in the analytics applications;
- Administer the data analytics platform and the servers supporting systems within the clinical development and quality management area;
- Provide user support and maintenance of systems and analytics applications according to the applicable ITIL based processes;
- Create Quality Assurance documentation, including test scripts to ensure compliance with CSV and/or GxP requirements;
- Manage the CSV activities, including testing to guarantee a timely roll out of the developed analytics applications;
- Support integration needs for clinical and quality systems.
Qualifications and Experience:
- University degree in software engineering or computer science, or a related field. Master’s degree is an advantage;
- Approximately three years of professional experience with preferably one year in the pharmaceutical industry;
- At least two years of hands-on experience in data analytics or software development.
- Strong analytical skills and a solid knowledge of data analytics and visualization software, including their scripting language;
- A strong knowledge of data storage and data integration technologies: different databases, SQL, JSON, XML, CSV and RESTful APIs. Knowledge of an ETL tool is an advantage;
- A solid understanding of the Clinical Data flow, the related business processes/systems (e.g. SAS, R, Metadata Repository) and awareness of the applicable standards (e.g. CDISC);
- Fluency in a general-purpose programming language (Python, Java, or others);
- Good communication and language skills, to efficiently engage with the business stakeholders and quickly translate their needs into technical documentation;
- A good understanding of general enterprise and data architecture principles;
- Ability to deliver high quality support for the systems and applications in scope;
- Independent, hands-on working style, team player, highly self-motivated, proactive and change oriented;
- Fluent in English (written and spoken), French and/or German is a plus;
- Relevant working/residency permit or Swiss/EU-Citizenship required.