Clinical DATA management / CDISK
Edison-New Brunswick Metro Area, NJ
I. POSITION SUMMARY:
This position will function as a subject matter expert on the Clinical Standards team. The primary role is to provide answers, recommendations, best practices, and guidance on the CDISC models (CDASH & SDTM).
Understand current direction and development of Industry Standards and their adoption by the Regulatory Agencies.
The position is also responsible for leading projects that will ensure that Clinical Data Standards are developed in alignment with established processes and procedures, maintaining agreed upon CDS content, and helping to ensure global adoption and organizational accountability for adherence to CDS.
II. PRIMARY JOB RESPONSIBILITIES:
Leads stakeholders across functional lines and management levels to assure support for and conformance to data standards initiatives.
Leads efforts to integrate standardization into current processes throughout the global clinical trial process.
Function as a subject matter expert on the Clinical Standards team
Foster an effective and cohesive team environment within the group and with other functional areas.
Serve as Liaison between Clinical Standards and other functional groups/vendors within the organization to provide leadership and guidance on the implementation of data standards.
Collaborates in efforts to integrate standardization into current processes throughout the global clinical trial process.
Work with stakeholders across functional lines and management levels to assure support for and conformance to data standards initiatives.
Understanding of data collection and CDASH
The primary role is to provide answers, recommendations, best practices, and guidance on the CDISC SDTM model.
Review and understand new SDTM IGs, as well as TAUGs and Standard Controlled Terminology.
Review SDTM mappings, acrf.pdf annotations, csdrg.pdf and define.xml.
Review in-development SDTM study packages and provide feedback and guidance to Statistical Programming.
Review submission SDTM study packages to ensure the packages are complete, including all functionality within the publishing files; define.xml, acrf, csdrg, etc., and ready to be submitted to the regulatory agencies.
Maintain the Laboratory Test Specifications and Conversion of laboratory tables.
A minimum of 7 years of experience in Clinical Development and Data Standards.
A strong understanding of clinical trial lifecycle processes
An in-depth understanding of CDISC standards (CPT, TAUGs, CDASH, SDTM, ADaM, define XML, Standard Controlled Terminology, etc.).
Good knowledge of ICH, FDA, GCP, and HIPAA regulations and guidelines
Knowledge, Skills, and Abilities
Excellent verbal and written communications skills
Excellent interpersonal skills
Capable of working collaboratively in a team environment
Ability to complete deliverables on time and adjust priorities in a fast-paced environment
Knowledge of eCRF design and annotations, particularly CDASH standards
Familiar with data dictionary concepts
Knowledge of data submission requirements.
Excellent organizational skills with great attention to detail and the ability to multitask?