EDC/eCRF Design Developer
Collegeville , Pennsylvania
April 09, 2017
Basic qualifications:
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.

Preferred qualifications:
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

Contact information:

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