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Principal Standards Analyst - NJ in Madison, NJ at APEX Systems

Date Posted: 1/10/2019

Job Snapshot

Job Description

Job #:  927891

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 such as CDASH and other data collection functions. 
  • 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. 
  • Data Collection Support:
    • Responsible for leading the standardization of eCRFs, external data specifications (Labs, ECGs, eCOA, etc.) and Controlled Terminology. 
    • Lead efforts and work groups to evaluate the impact of implement new versions of Standard data models; such as CDASH. 
    • Lead the implementation of new Therapeutic Area User guides across CDASH. 

Minimum Requirements:

  • A Bachelor's Degree or above is preferred with emphasis on life-science 
  • Knowledge/Experience: 
    • A minimum of 5 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, Standard Controlled Terminology, etc.). 
  • Good knowledge of ICH, FDA, GCP, and HIPAA regulations and guidelines

 

 

 

 

 

 

 

 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178