Study Data Manager

vor 3 Wochen

Berlin, Deutschland Oracle Vollzeit

Job Scope:

- Member of Study Team 

- Ensure accuracy and completeness of the study relevant databases or a study-specific, equivalent tool 

- Manage all data handling procedures within a study according to the study design (as necessary, after consultation with the Principal Investigator and Project Manager) and assure consistency with data management standards 

- Manage/supervise all technical aspects concerning management of study data 

Primary Duties: 

- Support the Project Manager regarding development of study questionnaires and eCRFs 

- Preparation, configuration and maintenance of the study relevant databases or electronic data capture systems (EDC) regarding item definition and database structure, data entry screens and plausibility checks according to data management standards and study needs 

- Coordination of all data management activities related to the study including training of and communication with local subcontractors 

- Contribute to the development of the study-specific working procedures and data management SOPs and guidelines 

- Organize the testing of data entry screens, databases, plausibility programs and UAT procedures

 - Plan, organize and monitor the data collection process (including questionnaire processing) and manage the data entry process (including data coding) 

- Organize educational measures including general data handling related topics and study-specific instructions 

- Oversee the conduct and compilation of data validation checks, results review and decision making, as well as data correction and documentation 

- Preparation of study data for statistical analyses using standards (CDISC) and specific procedures 

- Database lock and closure activities of study relevant databases or electronic data capture systems 

- Assignment of non-study specific tasks for ongoing data management projects

Career Level - IC2

- Academic degree or certificate(s) of achievement demonstrating relevant expertise in medical informatics, information science, computer science or related areas

- Experience in clinical or epidemiological data management 

- Significant experience with management of medical and/or health related study data 

- Experience in SQL 

- SAS programming skills 

- Fluent in German and good knowledge in English (written and verbal) 

- Ability to work in a team

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