Clinical Data Management Programmer (m/f/d)
Munich, Bavaria, Germany
Job Description
Cerner Enviza (an Oracle company) is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research.With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.
The Senior Specialist Data Management Programming supports the Data Management Programming team in conduct of data management programming tasks for clinical trials and/or non-interventional studies (NIS). They are a member of the project team, assisting the internal activities within the data management programming in line with project management decisions. Typical activities are preparatory steps associated with establishment and maintenance of programs, tools, procedures and interfaces for gathering data, reporting and transferring data with guidance from more experienced staff, drafting programming specifications and documentation of testing study data deliverables in compliance with relevant SOPs, Sponsor guidelines and regulatory requirements.
KEY OUTCOMES
- With guidance from more experienced staff, draft SAS annotations and SAS specifications according to the sponsor or CDISC standard and in project scope
- Assist with and/or oversee the programming and validation of sponsor specific SAS datasets (e.g. SDTM structure) in project scope
- Provide input and assistance in programming and validation of status reports and listings for internal and external use
- Participate in processing and administration of external data (e.g. laboratory data)
- Creation and review of study specific validation procedures and testing of e.g. eCRF templates (UAT) based on provided examples
- Support in the creation of documents for data management (Data Management Plan, Data Management Report, Data Validation Plan) and reports
- Participate in design of (e)CRFs
- Supervised collaboration with statistics and EDC programming
- Processing, administration and cleaning of data from clinical and non-interventional studies
- Support of the development of new and in the enhancement of existing company specific macros and tools
- Support standardizing of data management programming procedures
Working Environment
Hybrid or Remote
This position offers a Hybrid or Remote working environment. Meaning if you live within a metro area of a Cerner office, you will split working time between a Cerner office and remote. If you are not within a metro area of a Cerner office, you can live and work in your current geographical location and work primarily remote. #LI-Hybrid #Remote