Talentify.io
Senior Analyst, Data Standards (Remote)
Talentify.io, Little Ferry, New Jersey, us, 07643
Employer Industry:
Pharmaceutical
Why Consider This Job OpportunityCompetitive pay up to $130,000Opportunity for career advancement and growth within the organizationRemote work opportunity within the USComprehensive benefits package including medical, dental, and vision coverageChance to contribute to innovative medicines and solutionsCollaborative and supportive work environmentWhat To Expect (Job Responsibilities)Define SDTM mapping and data collection standards within assigned therapeutic areasEducate the organization on the proper use of standards in pipeline activitiesCreate and review SDTM Mapping Specifications and Trial Design DomainsProvide feedback on CRF design and SDTM datasets to ensure compliance with CDISC standardsOversee the creation of SDTM define.xml, annotated CRF, and Clinical Study Data Reviewer's GuidesWhat Is Required (Qualifications)MS with 6 years of relevant clinical research experience or BS with 8 years of relevant clinical research experienceExpert knowledge of CDASH, SDTM, ADaM, define.xml, and controlled terminologyExperience in mapping and converting legacy data into SDTM domains for eCTD submissionsKnowledge of international regulations related to clinical data standardsExperience with metadata repository technology or data standards governanceHow To Stand Out (Preferred Qualifications)Familiarity with clinical data standards including BRIDG, ODM, and SHARE
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Pharmaceutical
Why Consider This Job OpportunityCompetitive pay up to $130,000Opportunity for career advancement and growth within the organizationRemote work opportunity within the USComprehensive benefits package including medical, dental, and vision coverageChance to contribute to innovative medicines and solutionsCollaborative and supportive work environmentWhat To Expect (Job Responsibilities)Define SDTM mapping and data collection standards within assigned therapeutic areasEducate the organization on the proper use of standards in pipeline activitiesCreate and review SDTM Mapping Specifications and Trial Design DomainsProvide feedback on CRF design and SDTM datasets to ensure compliance with CDISC standardsOversee the creation of SDTM define.xml, annotated CRF, and Clinical Study Data Reviewer's GuidesWhat Is Required (Qualifications)MS with 6 years of relevant clinical research experience or BS with 8 years of relevant clinical research experienceExpert knowledge of CDASH, SDTM, ADaM, define.xml, and controlled terminologyExperience in mapping and converting legacy data into SDTM domains for eCTD submissionsKnowledge of international regulations related to clinical data standardsExperience with metadata repository technology or data standards governanceHow To Stand Out (Preferred Qualifications)Familiarity with clinical data standards including BRIDG, ODM, and SHARE
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