· 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).
· 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.
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).
About Eurofins Central Laboratory
Eurofins Central Laboratory is a dynamic, global organization fully dedicated to providing global central laboratory services to support all phases of clinical trials. At Eurofins Central Laboratory, we are
BOLD
. We go beyond the expected. Since we are purely a central laboratory, there are no distractions allowing us to remain laser-focused on the best science, technology, and people.
We are part of one of the world’s leading laboratory organizations Eurofins Scientific, therefore we offer end-to-end testing solutions which are unsurpassed in the industry. Eurofins Central Laboratory is setting new standards with GLP capabilities embedded within our Central Laboratory. We support our customers with laboratory facilities in the USA, Europe, Singapore, and China, and a back-office in India.
