Data Manager/statistician

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Department: Vaccine & infectious disease institute
Regime Full-time

Let’s shape the future - University of Antwerp

The University of Antwerp is a dynamic, forward-thinking university. We offer an innovative academic education to more than 20,000 students, conduct pioneering scientific research and play an important service-providing role in society. With more than 6000 employees from 100 different countries, we are helping to build tomorrow's world every day. Together we push back boundaries and set a course for the future – a future that you can help to shape. 

The Global Health Institute and the Centre for the Evaluation of Vaccination of the Faculty of Medicine and Health Sciences at University of Antwerp (UAntwerp) is looking for a full-time (100%) Data Manager/statistician.

The Global Health Institute's (GHI) mission is to conduct research aimed at improving the health of people worldwide, build capacity for global health research and engage in the implementation and evaluation of evidence-based interventions for health problems in low- and middle-income countries. Research activities cover different areas such as reproductive health, chronic disease management, (neglected) infectious diseases and vaccine-preventable diseases (www.uantwerpen.be/en/rg/global-health-institute).

The Centre for the Evaluation of Vaccination (CEV) specialises in initiating and conducting clinical (vaccine) studies to contribute to science, prevention of infectious diseases, and adequate health policies for all (https://www.uantwerpen.be/nl/onderzoeksgroep/cev/).

Background

There is a great need for a vaccine that can prevent or mitigate Mpox outbreaks in vulnerable populations. Recently, an Mpox strain of clade 1, which is sexually transmissible, has led to a cluster of infections in regions of the Democratic Republic of Congo (DRC). As a result, the DRC is facing the largest ever increase in Mpox cases. Since 1 January 2023, nearly 19,000 suspected cases of Mpox and more than 1,000 deaths have been reported in the DRC. While Mpox often leads to limited disease, it can cause severe complications, particularly in vulnerable populations such as infants/children and pregnant women. The effectiveness of current vaccines against clade 1 Mpox is uncertain, but data from animal trials are promising.

As part of the PIPoxVac consortium (where Antwerp University is coordinator), we will conduct a phase 3 randomised vaccine trial of a two-dose Mpox vaccine in healthy pregnant and postpartum women and children between 6 months and 2 years old. This study will assess the safety, immunogenicity, and (if possible) efficacy of the vaccine in these populations. We are also conducting a social science study on vaccine hesitancy and participation in vaccine research to inform research design and implementation approaches.

Therefore, the Global Health Institute and the Centre for the Evaluation of Vaccination are looking for a data management and statistical expert to both conduct quality research and create and maintain quality databases within the PIPoxVac project.

Position

• Development of databases and data specifications, including design, user requirements and access rights, building in controls, validating data;
• Development and maintenance of all data management documentation (SOP, work instructions, study-specific data management documents);
• Perform quality assurance/quality control-checks of data captured in the clinical database, in line with company quality standards and coordinate timely database corrections with clinical sites;
• Maintain databases throughout their life cycle to ensure data integrity, generate and review documentation regarding database changes;
• Reviewing clinical data;
• Monitor and track data entry and resolve queries according to agreed timelines;
• Assist in monitoring study statistics and site performance;
• Assist in standardising procedures around meta-data management;
• Coordinate archiving of study databases and related documents (including backup, optimisation, integrity verification);
• Assist in the procurement of software, hardware and data storage upgrades;
• Be willing to make regular field visits to DR Congo (and possibly other African countries) to oversee data management or related activities and install necessary software;
• Provide training on data management to the study teams (in Belgium and international institutions);
• Assume responsibility for leading, supervising and monitoring the data management activities of the clinical research organisation (CRO);
• Managing potential protocol violations/deviations within clinical studies;
• Perform sample size calculations;
• Analysing collected data in R or SAS;
• Optional: teaching activities on data management;
• Optional: creation and management of project website.

Profile

• Minimum master's degree in Epidemiology, Computer Science, Statistics, Computer Engineering or a related field;
• Good understanding of clinical studies and knowledge of or training in ICH Good Clinical Practices;
• High proficiency with MS Office;
• Experience in Electronic Data Capture systems (e.g. RedCap);
• Computer experience in database, spreadsheet and analysis software (e.g. R, SAS, Python);
• Knowledge of basic medical terminology is required, as well as scientific and clinical research methods;
• Knowledge of and experience with industry standards related to data management, i.e. CDISC, SDTM, ADaM, is a plus;
• Ability to work with large data sets with attention to detail;
• Ability to apply knowledge and skills effectively in a highly organised manner, adhering to legal guidelines and standard operating procedures;
• Excellent organisational skills and good analytical / problem-solving skills;
• Strong interest in scientific work, flexible attitude and strong sense of initiative and responsibility;
• Good communication skills;
• Excellent knowledge of English, basic knowledge of French (or willing to learn); knowledge of Dutch is a plus;
• Ability to work in a team and if necessary independently, to (train) the study team, in Belgium and in Africa;
• Ability to work productively with minimal supervision and meet deadlines;
• Willing to travel to (remote) sites in Africa;
• Experience working with/in developing countries (preferably in Africa) is a great asset;
• Experience as a (clinical) data manager and data analysis is an asset.
• Experience in creating and maintaining a website is a plus.

Reporting

You will report to and be supervised by the PIPoxVac project manager, who has a direct functional link with the Principal Investigators of this clinical trial at UAntwerp.

What we offer

• Working in an intellectually stimulating, international and interdisciplinary research environment, with room for personal initiative;
• A fixed-term contract of 12 months for 1 FTE position, with perspective of extension for at least another 2 years;
• Start date: November 1^st 2024;
• You will receive a gross monthly salary within pay band 6.1-8.1 of the pay scales of the Administrative and Technical Staff. Your entry-level grade depends on your relevant professional experience. More information on our pay scales and other benefits can be found here on our website.
• You get meal vouchers, eco vouchers, internet connectivity allowance, group insurance, guaranteed income insurance, and a bicycle allowance or full reimbursement of your commute by public transport;
• You will work largely at Campus Drie Eiken with in a dynamic and stimulating working environment and flexible working time arrangements. 

How to apply

• You can apply for this job through the University of Antwerp’s online job application platform until September 16^th, 2024, 24h CET. Click on 'apply for job', complete the online application form and don’t forget to include the following document: motivation letter and your CV.
• The selection committee will review all applications as soon as possible after the application deadline. Once a decision has been made, we will notify you and inform you of the possible next step(s) in the selection procedure.
• If you have any questions about the content of the job or the PIPoxVac project, please contact Dr. Ynke Larivière, ynke.lariviere@uantwerpen.be. Prof. Pierre Van Damme, pierre.vandamme@uantwerpen.be (head of CEV) or Prof. Jean-Pierre Van geertruyden, jean-pierre.vangeertruyden@uantwerpen.be (head of GHI). If you have any questions about the online application form, please check the Frequently Asked Questions or send an email to jobs@uantwerp.be.

The University of Antwerp is a sustainable, family-friendly organisation which invests in its employees’ growth. We aim to foster diversity and attach great importance to equal opportunities, regardless of gender identity (M/F/X), disability, race, ethnicity, religion or belief, sexual orientation or age. We encourage people from diverse backgrounds and with diverse characteristics to apply.