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CDISC Consultant (Senior) Home Based

Job Description

Ockham is a global provider of resources to the Biotechnology and Pharmaceutical Industry. We work with companies involved with clinical trials and other market approval processes to help them deliver their products on time and on budget. One of our clients is looking for a CDISC Consultant / Senior CDISC Consultant . This is a contract position.

The CDISC Consultant
will work in the CDISC Consultancy Group (CCG). The CCG is primarily responsible for supporting the compliant and consistent adoption of the CDISC Study Data Tabulation Model (SDTM). This position will be based at South San Francisco site but can work remotely in the US. The role will provide SDTM consultancy support for new and ongoing studies and involve close collaboration with SDF Implementers, Biostatistical Programmers, and Global Librarians.

•Participate in SDF implementation and study team meetings to provide expert advice on SDTM mapping
•Resolve study level mapping issues in a timely manner and escalate global issues for CCG leadership discussion
•Contribute to team and process documentation
•Work with project manager and the Senior CDSIC Consultant to ensure timely deliverables for study milestones
•Follow standard convention to provide SDTM annotation on CRFs
•Work with Global Librarians to manage SDTM Controlled Terminology

The Senior CDISC Consultant will work in the CDISC Consultancy Group (CCG). The CCG is primarily responsible for supporting the compliant and consistent adoption of the CDISC Study Data Tabulation Model (SDTM). This position will be based at South San Francisco site but can work remotely in the US. The role will provide SDTM consultancy support for new and ongoing studies and involve close collaboration with SDF Implementers, Biostatistical Programmers, Global Librarians and Data Stewardship Representatives.

•Participate in SDF implementation and study team meetings to provide expert advice on SDTM mapping
•Resolve study level mapping issues in a timely manner and escalate global issues for CCG leadership discussion
•Host CCG team meetings and prepare meeting agenda and minutes
•Lead other CDISC Consultants on CRF annotation and SDTM Controlled Terminology Management
•Contribute to team and process documentation
•Serve as Therapeutic Area Global Librarian to maintain SDTM Controlled Terminology
•Perform SDTM audits and conformance checks to ensure SDTM compliance
•Assist study teams in defining and developing submission documentation including define.xml and reviewers guide
•Work with project manager and other CDSIC Consultants to ensure timely deliverables for study milestones
•Support standard process improvement initiatives

Job Requirements

CDISC Consultant:
•BA/BS or higher degree in Computer Science, Statistics, Mathematics, Life Sciences, other related scientific subject
•5 years of pharmaceutical/biotech industry experience
•3 years of SDTM consulting experience – conformance assurance, standardization, harmonization, liaising, problem-solving
•In-depth knowledge on SDTM standard – official training from CDISC preferred
•Hands-on experience on CRF annotation with SDTM mapping
•Experience on managing SDTM controlled terminology – subscribing, updating, versioning
•Effective oral and written communication
•Good documentation practice
•Willingness and ability to learn and follow standard processes and procedures in team environment
•Ability to work proactively and independently

Senior CDISC Consultant:
•BA/BS or higher degree in Computer Science, Statistics, Mathematics, Life Sciences, other related scientific subject
•7 years of pharmaceutical/biotech industry experience
•5 years of SDTM consulting experience – conformance assurance, standardization, harmonization, liaising, problem-solving
•In-depth knowledge on SDTM standard – official training from CDISC preferred
•Active member of CDISC Submission Data Standards (SDS) team highly preferred
•Thorough understanding and experience on data quality and compliance checks – DAT, WebSDM, OpenCDISC
•Prior regulatory submission experience with SDTM data and define.xml
•Project management experience – prioritizing, resourcing, following timeline, issue tracking
•Prior leadership or management position
•Effective oral and written communication
•Good documentation practice
•Willingness and ability to learn and follow standard processes and procedures in team environment 

 


Job Snapshot

Employment Type Contractor
Job Type Biotech, Pharmaceutical
Education 2 Year Degree
Experience 3 to 14 years
Manages Others No
Industry Biotechnology, Pharmaceutical
Required Travel Not Specified
Job ID 5440 & 5439
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CDISC Consultant (Senior) Home Based


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