REMOTE: "Sr. EDC Validation Consultant"

3 weeks ago


Lexington, United States Maxis Clinical Sciences Full time
Job DescriptionJob Description

Role is with one of our direct major pharma sponsor. This is very long term FSP project and purely based on extensive EDC experience. Candidates having no expertise in EDC, requested not to apply.

Must have experience with EDC Validation.

Need to have some testing experience as well.

Experience with UAT, Library and data listings.

Must have experience with  HP- ALM.

Job Title: Senior Validation Consultant
Job Description:

  • Providing support in Quality Assurance process awareness and adherence and supporting in preparation/review process related documents like SOP's (Standard Operating procedures), Work Instructions (WIS) for the support process
  • Experience in UAT, Library and data listings
  • Review of URS document and understand the functionality
  • Responsible for all the validation deliverables as per compliance
  • Enable change management at the customer, based on change management recommendations
  • Draft, review and execute the IQ/OQ (Test Protocols) scripts
Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.

Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r
\r
Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.
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