Data manager/statistician

• Development of databases and data specifications, including design, user requirements and access rights, building in checks and validating data;
• Development and maintenance of all documentation regarding data management (SOP, work instructions, study-specific documents for data management);
• Performing quality assurance and quality control of data recorded in the clinical database, in accordance with company quality standards, and coordinating timely database corrections with clinical sites;
• Maintenance of databases throughout their entire lifecycle to ensure data integrity, and drafting and reviewing documentation regarding changes in the database;
• Review of clinical data;
• Monitoring and tracking data entry and resolving queries according to agreed timelines;

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• Assisting in monitoring study metrics and site performance;
• Assisting in standardizing procedures around metadata management;
• Coordinating the archiving of research databases and associated documents (including backup, optimization and integrity checks);
• Assisting with the procurement of software, hardware and upgrades for data storage;
• Willingness to make regular field visits to the DR Congo (and possibly other African countries) to oversee data management or related activities and to install necessary software;
• Providing training on data management to research teams (in Belgium and at international institutions);
• Taking responsibility for leading, guiding and controlling the data management activities of the clinical research organization (CRO);
• Handling potential protocol violations/deviations within clinical studies;
• Calculating the required sample size;
• Analyzing collected data in R or SAS;
• At least a master's degree in epidemiology, statistics or a related field;
• Good insight into clinical studies and knowledge of or training in ICH Good Clinical Practices;
• Excellent command of MS Office;
• Experience with Electronic Data Capture systems (e.g., RedCap, Medrio, etc.);
• Computer experience with database, spreadsheet and analysis software (e.g., R, SAS, Python);
• Knowledge of basic medical terminology is required, as well as knowledge of scientific and clinical research methods;
• Knowledge of and experience with industry standards in data management, such as CDISC, SDTM and ADaM, is a plus;
• The ability to work with large datasets with attention to detail;
• The ability to apply knowledge and skills effectively in a highly organized manner, in compliance with legal guidelines and standard operating procedures;
• Excellent organizational skills and good analytical and problem-solving skills;
• Great interest in scientific work, a flexible attitude and a strong sense of initiative and responsibility;
• Good communication skills;
• Excellent knowledge of English, good knowledge of French; knowledge of Dutch is a plus;
• The ability to work in a team and, if necessary, independently;
• The ability to train the research team, both in Belgium and in Africa;
• The ability to work productively with minimal supervision and meet deadlines;
• Willingness to travel to (remote) locations in Africa;
• Experience working in developing countries (preferably in Africa) is a major asset;
• Experience as a (clinical) data manager and with data analysis is a plus.

Reporting

You report to and are under the supervision of the Senior Data Manager and Project Manager of PregInPoxVac or Tumaini, who have a direct functional link to the principal investigators of this clinical study.