Experienced eCRF developer who can lead study teams to deliver an eCRF based on protocol requirements. Has proven experience in creating eCRF specifications, managing eCRF timelines, designing and developing eCRFs.
o Bachelor of Science degree or related field.
o Minimum 5 years experience creating eCRFs using any of the eDC tools (ex: Central designer, RAVE etc)
o Minimum 5 years in defining data set specifications.
o Minimum 5 years in leading eCRF development with a cross functional study team, vendors and working in matrix organization to meet timelines and deliverables
o Experience with data management tools, technologies and processes
o Ability to learn new process, programming languages and adapt with new technologies
o Define and lead study teams for eCRF trial development, specification and rules programming for a given protocol
o Provide oversight of vendors to ensure they are delivering based on the requirements and specifications
o Implementation of GSK and SDTM standards
o Serve as technical expert for Therapeutic area and project support.
o Assess database design requirements relevant to data capture tool, data extraction, processing and reporting.
o Manage the Design specification, development, testing and validation of electronic case report forms, edit checks standards and dataset extraction.
o Make recommendations to management concerning complex technical issues and provide solutions.
o Have a complete e2e technical and strategic understanding of products relevant to clinical data management.
o Be knowledgeable in regulatory requirements for electronic submissions.
o Accountable for audit readiness for data acquisition process and documentation
o Able to manage multiple studies and projects simultaneously and deliver on the timelines
You may apply for this position online by selecting the Apply now button.
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