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Principal Standards Analyst
Ref No.: 18-12326
Location: Madison, New Jersey
Position Type:Contract
Start Date / End Date: 09/04/2018 to 12/31/2018
Sunrise System Inc. is currently looking for Principal Standards Analyst in Madison, NJ with one of our top client.
Job Title: Principal Standards Analyst
Job Id: 18-12326
Location: Madison, NJ 07940
Duration: 3 months
Position Type: Hourly contract Position (W2 only)
 
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. 
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 
SDTM Support
  • 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. 
Knowledge/Experience
  • 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, defineXML,
  • 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" 
Contact
Vishal Tejaswi
Desk:732- 272 -0312 | Email: vishal.t@sunrisesys.com
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com