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Data Manager/statistician
Data Manager/statistician
Job description
- 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.
Offer
- Meal vouchers
- Parking
- Public transport contribution
- Eco Cheque
- Training
- Additional paid leave
- 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 1st 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.
- You can apply for this job through the University of Antwerp’s online job application platform until September 16th, 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, Show emailaddress. Prof. Pierre Van Damme, Show emailaddress (head of CEV) or Prof. Jean-Pierre Van geertruyden, Show emailaddress (head of GHI). If you have any questions about the online application form, please check the Frequently Asked Questions or send an email to Show emailaddress.
Practical information
see vacancy text
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