Technical Clinical Data Programmer

Functional Services Boston, Massachusetts United States


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 Technical Clinical Data Operations Specialist to join our team! Working at Premier Research means being an individual - you will be recognized 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:

  • Develops and maintains clinical data standards, including operational (electronic Case Report Form (CRF) global library standards), Study Data Tabulation Model (SDTM), controlled terminology, external data mappings (e.g., lab or electrocardiogram), and other applicable standards
  • Works across the portfolio and Clinical Study Teams to increase automated reporting (JReview®, SAS) and review in order to streamline effort on data intensive studies
  • Develops of 'smart' reports, identifies efficiencies and trends in ongoing review, and develops best practices and data flow solutions
  • Enhances available reporting tools or creates new ones to support the review of clinical trial data and trial status information for cross-functional use
  • Creates Standard Operating Procedures (SOPs), best practices, educational series, global work streams related to data standards, trial/data status reporting and clinical database creation and testing
  • Leads/performs activities related User and Site Account Administration and Maintenance within Clinical Data Management Systems (CDMS) and Electronic Data Capture (EDC) including the definition of best practices and SOPs
  • Leads/performs Clinical Trial Management System (CTMS) Technical Administration including the definition of best practices and SOPs
  • Ensures vendors support technical data management activities to meet or exceed industry standards related to clinical data collection, processing and quality
  • Liaises with Clinical Research Organizations, EDC vendors and other third-party vendors in a project-manager capacity in support of timelines and data-related technical deliverables.
  • Performs additional duties and assignments as designated.

You’ll need this to be considered:

  • Bachelor degree, or international equivalent from an accredited institution, preferably in a programming, technical, clinical, or health-related field, or equivalent combination of education, training and experience
  • 3 to 5 years of practical experience using commercial clinical data management systems (eg – Oracle RDC / Inform, Medidata Rave, Datalabs, etc) or data visualization tools (e.g. Spotfire, jReview).  Alternatively, must have proven experience in all primary job functions
  • Demonstrates excellent English verbal and written communication skills
  • Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)
  • Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
  • Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
  • Practical experience with CDISC SDTM preferred