EDC Validation Resource (CSV) with Pharma - Remote

Job Description

Description:

· Senior Validation resource (CSV) with experience in UAT, Library and data listings.

· EDC Validation experience required.

· 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.

· Must have experience with HP Client-ALM.

· 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 Description

Maxis 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.