Data Manager for Sema-react

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Departement: Huisartsgeneeskunde en Bevolkingsgezondheid
Regime Voltijds

**Let’s shape the future - University of Antwerp**

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The **Global Health Institute** of the Faculty of Medicine and Health Sciences at the University of Antwerp (UAntwerp) is looking for a full-time (100%) **Data Manager for SEMA-REACT.**

**Background**

Annually, almost 500,000 children under 5 years die from malaria in Africa. Timely access to effective antimalarial therapies is life saving and leads to an observed 96% reduction in mortality. Though, the full treatment paradigm is not always feasible when access to primary healthcare facilities is limited due to lack of transport, nonavailability

of services, and cost. The rollout of rectal artesunate (RAS)has recently been paused as outcomes data is incomplete in these contexts making the development of best practice recommendations challenging. Hence the relevance of the proposed study, an observational, non-inferiority study in Zambia and DRC. Community Health Care Workers will identify/diagnose, treat and follow up patients with (severe) malaria as part of integrated community case management. We will compare the efficacy and assess and mitigate operational and institutional facilitators and barriers in all stakeholders (patients, caregivers, health care providers, regulators, and malaria experts) and recommend sustainable policies for this remote context. This generated evidence will support policy development and implementation.

The proposed consortium brings together vital experience in the rollout and deployment of rectal artesunate, study design and execution, social science, data collection and management, stakeholder engagement and translation of research results into clinical

practice.

Therefore, the Global Health Institute is** looking for experts in data management to join and strengthen their team in order to perform high quality research and create and maintain high quality databases within the SEMA REACT project.**

**Position**
- Merge, and develop databases and database data specifications, including design, user requirements, edit rules/checks, query logic and data validations; access permissions and privileges.
- Develop and maintain all Data Management (DM) documentation (Data management plan, standard operating procedures, work instructions, and study-specific DM documents).
- Performing QA/QC checks of the data recorded in the clinical database in line with the company’s quality standards and coordinating timely corrections to the database with the clinical sites.
- Maintain databases throughout their lifecycle to ensure data integrity, generate and review documentation for all database changes or refinements.
- Perform clinical data review of data listings and summary tables.
- Overseeing and tracking data entry and query resolution following agreed timelines.
- Assist with monitoring study metrics and site performance using standard data management tools.
- Assist in standardizing metadata management procedures.
- Coordinate the archiving of study databases and related documents (including backup, optimization, and verification of integrity).
- Assist in decisions regarding the acquisition of software, hardware and data storage upgrades.
- Perform regular field visits to DR Congo to supervise data management-related activities and install software.
- Provide training on data management to study teams (in Belgium and international settings including remote areas in Africa).
- Manage potential deviations from the protocol.
- Optional: data management teaching activities.

**Profile**
- Minimum bachelor’s degree in Computer Science, Statistics, Computer Engineering or a related field.
- More than 3 years of experience as a (clinical) data manager (data analytical experience is a plus).
- Good understanding of surveillance data, Monitoring & evaluation, process evaluation, clinical trials and knowledge of or training on ICH Good Clinical Practices
- High proficiency with MS Office.
- Computer experience in database, spreadsheet, and analysis software (i.e. SAS, R, SQL, Python, Perl) and/or experience in EDC systems.
- Familiarity with basic medical terminology is required, as well as knowledge of scientific investigative and clinical research methodologies.
- Knowledge about and ex