EDC/eCRF Design Developer
Location:
Collegeville , Pennsylvania
Posted:
April 09, 2017
Reference:
WD83764
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

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

Contact information:

You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

A little about us:
We are a science-led global healthcare company on a mission to help people to do more, feel better and live longer.

Know someone who would be interested in this job? Share it with your network.