eCRF / Database Developer
Eurofins
Bengaluru, Karnataka, India
Company Description Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing. In 2020, Eurofins generated 4.2 billion Euro proforma turnover in 800 laboratories across 50 countries, employing about 50.000 staff. Eurofins Technologies is a new International Business Line (IBL) within the Eurofins Group focused on the development, manufacturing and marketing of bioanalytical technologies and diagnostic test kits in particular. The business if primarily focused on solutions in Food Safety and Environmental Safety but has recently expanded into Animal Health and Clinical Diagnostics. Eurofins Technologies serves both external customers (industrial laboratories, governmental laboratories, service laboratories) as well as customers within the Eurofins Group. Job Description · Assess database design requirements relevant to data capture tool, data extraction, processing and reporting. · Design database based on protocol and clinical data manager specifications. · Make recommendations to management concerning complex technical issues and provide solutions. · Configuration and validation of mapping for datasets export from EDC. · Program edit checks according to the specifications defined by the clinical data manager. · Provide support in the fixing of any issues or required changes to eCRF and Edit Checks encountered during system testing, User Acceptance Testing (UAT) and deployment testing. · Import external data in the EDC based on the Data transfer agreement developed in collaboration with the Clinical Data Manager and process. · Able to manage multiple studies and projects simultaneously and deliver on the timelines. · Able to provide support or manage edit checks testing and UAT if required. Archive study databases and related documents. · Participate in the review and development of Quality documents (SOP and working practices). Qualifications · Bachelor of Science degree or related field. · Experienced EDC / eCRF design developer to deliver an eCRF based on protocol requirements. · Knowledge and understanding of clinical research. Significant experience creating eCRFs using any of the eDC tools (eg: Oracle RDC, Lifesphere, Ennov, Inform,…). Proven experience in eCRF development with a cross functional study team to meet timelines and deliverables. Experience with data management tools, technologies and processes. Ability to learn new process, programming languages. Additional Information PERSONAL CHARACTERISTICS Eurofins has a culture of high professional standards, with strong processes, and an eye for details. Candidates will need to be fully aligned with this culture, which implies a structured and analytical approach, pragmatism, and modesty. EVOLUTION: In a fast growing group, successful leaders are frequently being offered increased areas of responsibility (subject to geographic mobility).
