Senior Standards Support Specialist - Contract - Home-based

Functional Services United States


Description

Position at Premier Research Group Limited

Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. We’re looking for a talented and energetic Standards Support Specialist to join our team! Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

You'll be accountable for:

  • Populates the Metadata Repository based on approved impact assessments and/or Case Report Form (CRF) specifications and annotations.
  • Creates CRF specifications and annotations based on impact assessments and documented decisions.
  • Populates the metadata in the global library of the clinical data management system (CDMS).
  • Creates new graphic CRF modules based on approved impact assessments
  • Posts Data File Specifications, Statistical Guidance Documents, and other related documents to the Metadata Repository.
  • Manages the standards work flow change control process via the change control system.
  • Trains and follows internal and sponsor's standard operating procedures as applicable.
  • Liaison with the sponsor as needed to resolve issues that cannot be resolved within the organization.
  • Performs additional duties as assigned.
You'll need this to be considered:
  • Bachelor degree, or international equivalent from an accredited institution, preferably in a technical field or equivalent combination of education, training and experience
  • 3 to 5 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions.
  • Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
  • Demonstrates excellent English verbal and written communication skills
  • Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
  • Familiarity with Clinical Data Interchange Standards Consortium (CDISC) standards preferred