- Datenbankentwicklung / BI
- Oracle DB - PL/SQL
- Quality Assurance
- SAS Analytics Software
The European Roche Molecular Solutions Clinical Operations and Biometrics (COBM) team is looking for clinical programmer / data manager to support non-registrational and registrational studies for RMS products from early development through post-launch phases.
The Clinical Programmer main responsibilities include transformation of data for loading, analysis and development of reports for clinical review. In addition, the clinical programmer may also be responsible for development, oversight and deployment of study databases.
- Act as a primary point of contact for assigned studies to perform data extraction and transformation support ensuring quality of the programming and adherence to company standards.
- Ensures data is extracted from the Electronic Data Capture (EDC) system in order for it to be available for data cleaning, reporting and analysis.
- Under general guidance, develops and modifies SAS programs for import, export and processing data in order to provide listings/reports to evaluate the clinical data.
- Facilitates activities regarding the design, development, documentation, user acceptance testing (UAT) and implementation of clinical study database (e.g. Marvin or Medrio).
- Programs and tests edit checks, derivation procedures and reports within the database.
- Maintains and develops laboratory databases to ensure its proper working and to facilitate work of study team
- Creates or modifies views or reports in the laboratory database to support the clinical study team request.
- Manages data discrepancy process to ensure discrepancies are generated and resolved in a satisfactory and timely manner as part of the study team. Uses professional judgment to escalate issues appropriately.
- Updates clinical database based on queries, and performs other database changes as necessary for a study.
- Bachelor or Master degree in scientific discipline required, or equivalent combination of education and work experience
- 2-3 years of experience with building a clinical database or working with clinical data management systems like (e.g. Medrio, Marvin, RAVE) in pharmaceutical, biotechnology, diagnostics or medical device environment
- Highly proficient in programming languages like SAS, SQL and PL/SQL
- Experience in working with relational databases (ORACLE)
- Knowledge of GCP requirements regarding clinical data management documentation and software is a plus
- Strong verbal and written communication skills
- Judgment skills to work accurately and efficiently toward quality result
- Excellent English speaking and writing skills, German is a plus
- Ability to work effectively in a cross-functional team at multiple locations in Europe and US