Duties/Pligte - Managing the collection, maintenance and delivery of high quality data throughout the duration of all research projects; - Contributing to the design and maintenance of databases and data collection tools, to ensure that they meet the requirements for entering and reporting clinical data of varying complexity; - Testing prototype databases and data entry systems to ensure compliance with the study protocol and institutional processes and procedures; - Testing new processes and systems for the optimal management of data in clinical research; - Processing, tracking and validating data accurately and in a timely manner, in accordance with the instructions for data processing and entry; - Managing the patient information and review protocol and incorporating protocol-specific guidelines into the data review process; - Taking primary responsibility for data quality; - Performing project-specific quality control and quality assurance tasks for each project independently; - Ensuring adherence to Good Clinical Practice, good clinical data management practices, and adherence to standard procedures and work instructions; - Developing and extracting accurate data reports as needed for ongoing project implementation and for data dissemination; - Attending regular sponsor-related meetings and feedback sessions; - Providing data required for invoicing; - Training and managing data staff as required (team leader); - Developing visiting calendars; - Attending all start of study training sessions; - Available to resolve queries as they are loaded; - Performing basic data analysis. - Bestuur die insameling, instandhouding en lewering van hoë gehalte data tydens die duur van alle navorsingsprojekte; - Dra by tot die ontwerp en instandhouding van databasisse en data-insamelingsinstrumente om te verseker dat hulle voldoen aan die vereistes vir die invoer en rapportering van kliniese data van wisselende kompleksiteit; - Toets prototipe databasisse en data-invoerstelsels om voldoening aan die studieprotokol en institusionele prosesse en prosedures te verseker; - Toets nuwe prosesse en stelsels vir die optimale bestuur van data in kliniese navorsing; - Verwerk, volg en valideer data akkuraat en betyds, in ooreenstemming met die instruksies vir dataverwerking en -invoer; - Bestuur die pasiëntinligting en hersieningsprotokol en inkorporering van protokol-spesifieke riglyne in die datahersieningsproses; - Neem die primêre verantwoordelikheid vir data-gehalte; - Voer projekspesifieke gehaltebeheer - en kwaliteitversekeringstake vir elke projek onafhanklik uit; - Verseker nakoming van Goeie Kliniese Praktyk, goeie kliniese databestuurspraktyke, en nakoming aan standaardprosedures en werksinstruksies; - Ontwikkel en onttrek akkurate dataverslae soos nodig vir deurlopende projek implementering en vir dataverspreiding; - Woon gereelde borgverwante vergaderings en terugvoersessies by; - Verskaf data wat benodig word vir fakturering; - Lei datapersoneel op en bestuur soos vereis (spanleier); - Ontwikkel besoekkalenders; - Woon alle studiebegin opleidingsessies by; - Beskikbaarheid om navrae op te los soos dit gelaai word; - Voer basiese data-analise uit. Job Requirements/Pos Vereistes - Five years' experience of data management in a research environment; - Experience with clinical data management systems (e.g., REDCap); - An excellent working knowledge of various database management software packages (e.g., SQL Server and MS Access); - Excellent query writing skills: T-SQL, ETL (extract, transform, load); - The ability to deal with large volumes of data accurately and efficiently; - The willingness to work flexitime; - The ability to work collaboratively in a team and to actively engage in skills transfer; - The ability to document data-related activities well and consistently; - The ability to work systematically and to integrate various sources of information and systems; - The ability to handle confidential information in a professional manner; - Good verbal and written communication skills. - Minstens vyf jaar se ervaring met databestuur, verkieslik in 'n navorsingsomgewing; - Ervaring met kliniese databestuurstelsels (bv. REDCap); - 'n Uitstekende werkskennis van verskillende databasisbestuur sagtewarepakkette (bv. SQL Server en MS Access); - Uitstekende skryfvaardighede vir navrae: T-SQL, ETL (uittreksel, transformasie, laai); - Die vermoë om groot hoeveelhede data akkuraat en doeltreffend te hanteer; - Die bereidwilligheid om flexi-tyd te werk; - Die vermoë om in 'n span te saam te werk en om aktief deel te neem aan vaardigheidsoordrag; - Die vermoë om dataverwante aktiwiteite goed en konsekwent te dokumenteer; - Die vermoë om stelselmatig te werk en verskillende bronne van inligting en stelsels te integreer; - Die vermoë om vertroulike inligting op 'n professionele wyse te hanteer; - Goeie mondelinge en skriftelike kommunikasievaardighede. Recommendation/Aanbeveling - REDCap knowledge will be advantageous; #J-18808-Ljbffr