EDC/eCRF Design Developer

Job description

Details:
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

If requiring an adjustment for a disability, once selected for Interview you may contact

Closing date for applications: 31st March 2017

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.

Thank you for your interest in this opportunity.

*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:
o Bachelor of Science degree or related field.
o Experienced EDC / eCRF design 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 Significant experience creating eCRFs using any of the eDC tools (ex: Inform Central designer, RAVE etc)
o Significant experience in defining data set specifications.
o Proven experience 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