Role Overview:<\/p>\n
\tThis unique role within IQVIA lends itself to a technically minded person with strong communication skills and SDTM knowledge. Having experience with SAS programming will be key for this position. The role can be based remotely from anywhere in Europe or in South Africa.
\n\tThis role is part of a sponsor dedicated project where you will be working with the client directly to manage Database SDTM Deliveries.
\n\tThe primary functions of this role will be to define SDTM specification and Programming including SDTM review ensuring quality and completeness of SDTM format data.<\/p>\n
Primary Functions:<\/p>\n
\tReview and programming of SDTM deliveries
\n\tBuild and review SDTM submission packages
\n\tEnsure quality and completeness of SDTM format data<\/p>\n
Main Responsibilities:<\/p>\n
\tCollaborate with Sponsor colleagues and CRO Partners to review SDTM
\n\tIn collaboration with Study Data Leads ensure the planning for data receipt and its oversight throughout the duration of assigned clinical trials
\n\tProgram reports and contribute to the standardization of process and reports used for data review and analysis for external partners\/vendors and internal teams
\n\tComplete formal and ad-hoc analyses and oversight of SDTM data.
\n\tReview of critical document\/deliverable (SDTM Annotation, SDTM datasets) to ensure Data Standards are used consistently and support creation of DE dataset
\n\tProgram either SDTM SAS PRD or SAS QC of some SDTM deliveries managed internally
\n\tAttend meetings as applicable with Mission, Submission, Project, Program, JCST, DEM, Biometrics, Clinical & Regulatory Solutions Team (CRST), Early Phase
\n\tPerform relevant quality checks and create standard edit checks for new CRF modules and share in the appropriate space
\n\tSupport audits and inspections as required and other responsibilities and projects that the Company may assign.<\/p>\n
Experience Required:<\/p>\n
\tAt least 5 years relevant SAS experience preferred
\n\tExperience with Biometrics processes, to include:
\n\tReview of SDTM annotated CRFs
\n\tWriting and reviewing technical specifications
\n\tReview of log files for errors and warnings
\n\tResolving\/trouble shooting errors
\n\tExperience with data mapping and SDTM Controlled Terminology
\n\tExperience with SAS programming and SDTM deliveries
\n\tPrior experience in a clinical or pharmaceutical related field is required.
\n\tPrior experience in a Data Management related field is required
\n\tExperience with relational databases, preferably Clinical Data Management and EDC Systems
\n\tAdvanced familiarity with reporting tools.
\n\tAdvanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.
\n\tExcellent command, both verbal and written, of English<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( https:\/\/www.iqvia.com ) or<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"","_company_name":"IQVIA","_company_website":"https:\/\/www.iqvia.com","_company_tagline":"Sharing a Vision to Drive Healthcare Forward Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increa... read moresingly limited resources. We are inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology and human intelligence to reimagine and deliver ways to help make them a reality. It\u2019s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It\u2019s about exploring a new path to better health outcomes via Human Data Science. It\u2019s about harnessing the power of the IQVIA CORE\u00e2\u201e\u00a2 to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers. Motivated by the industry we help, we\u2019re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward. Southdown's Ridge Office Park 2nd Floor, Unit 5 Corner Nellmapius & John Vorster Drive Irene Ext. 54 Centurion Pretoria South Africa 0169","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[25],"job-types":[12],"class_list":{"0":"post-35047","1":"job_listing","2":"type-job_listing","3":"status-publish","4":"hentry","5":"job_listing_region-free-state","7":"job-type-full-time"},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/35047","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/media?parent=35047"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=35047"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=35047"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}