Study Data Manager - Berlin, Deutschland - Oracle

Beschreibung

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