Senior Data Management Programmer (7177)
Senior Data Management Programmer – 7177
Our client is headquartered in Switzerland – a biotech-hub of Europe – is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options is looking a Senior Data Management Programmer for a initial 2 years contract based in Basel.
Main Responsibilities:
· Design, build, maintain and close clinical trial databases using EDC and paper-based systems.
· Develop and maintain CDISC-compliant data standards, mappings and documentation.
· Program data extractions, listings, edit checks, protocol deviation reports and custom functions.
· Implement and manage CRF and non-CRF data handling procedures.
· Test databases and validation procedures to ensure data integrity and quality.
· Monitor data management activities across multiple clinical studies.
· Identify process improvement opportunities and support implementation of innovative technologies.
· Support programming activities for regulatory submissions and audit requirements.
· Provide technical guidance and mentorship to team members.
Qualifications and Experience:
- Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
· Associate degree, Bachelor degree or equivalent in Mathematics, Informatics, Engineering or a related discipline.
· Minimum 5 years of programming experience within Clinical Data Management in a pharmaceutical company or CRO.
· Strong understanding of CDISC and SDTM standards.
· Hands-on experience with Clinical Data Management Systems, EDC platforms and data reporting tools.
· Knowledge of ICH-GCP, 21 CFR Part 11 and global clinical research regulations.
· Advanced English language skills.
· Clinical database design and validation.
· Database build, derivations, coding and discrepancy management.
· Clinical data reporting and extraction programming.
· Development of global data standards and mappings.
· Microsoft Office and Windows environment proficiency.