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. Cerner Enviza is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind.

　　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.

　　MISSION:

　　Lead the creation of and create SAS annotations and SAS specifications according to the sponsor or CDISC standard

　　Establish programming procedures and validation of sponsor specific SAS datasets (e.g. SDTM structure) and support less experienced team members to perform the programming in accordance with those procedures

　　Definition of programming and programming of status reports and listings for internal and external use, including validation steps

　　Coordinate the 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)

　　Participate in the creation of documents for data management (Data Management Plan, Data Management Report, Data Validation Plan) and reports, including templates review

　　Assistance with the design of (e)CRFs

　　Collaboration with statistics and EDC programming

　　Lead development of new and in the enhancement of existing company specific macros and tools

　　Initiate and coordinate data management programming procedures standardization

　　Consideration of the Data Management programming budget within assigned projects

　　Conduct quality control in order to ensure that the output meets quality standards and project requirements

　　Provide oversight to coordination and maintain organized, complete and up-to-date study documentation, testing and quality control documents

　　Qualifications

　　University degree in Medical Documentation/Life Science/Biological Science/Informatics or a related discipline in the science/healthcare field or equivalent educationSeveral years of experience in (Clinical) Data Management within a pharmaceutical company or CRO or an equivalent combination of education and experience to successfully perform the key responsibilities of the jobProgramming skills in SAS, SQL and Access databasesKnowledge and experience in CDISC SDTM desirablePerformance-oriented, well-structured and efficient work methodsAbility to work both independently and efficiently within an interdisciplinary teamExcellent planning, organisation, and communication skillsProficient computer skills in MS OfficeExcellent command of both written and spoken German and English

　　Additional Information

　　All employees must be legally authorized to work in the country where the position is located. Work visa sponsorship is not available for this position.

　　Company Overview

　　Cerner is a place where people are encouraged to innovate with confidence and focus on what is important - people's health and the care they receive. We are transforming health care by developing tools and technologies that make it more efficient for care providers and patients to navigate the complexity of our health. From single offices to entire countries, Cerner solutions are licensed at more than 25,000 facilities in over 35 countries.

　　Cerner's policy is to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Cerner is proud to be a drug-free workplace.