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Principal Clinical Data Standards Architect

Pharmaceutical Research Associates, Inc

US only
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Overview

  • Exciting and highly-visible full-time opportunity to work on a dedicated PRA team supporting an embedded client, a top-three (global) Pharmaceutical company
  • Ability to work with cutting-edge clinical technology and within PRA's Strategic Solutions Division (SSD); a.k.a. embedded program
  • Excellent career advancement potential
  • Ability to work fully-remotely

Summary: 

The CDSA implements standard content in data collections and delivery tools, with the goal of creating efficiencies within trials, consistency across multiple trials, and automating the CRF build and data flow from collection to SDTM.

Responsibilities

Data collection:

  • Implements efficient standards in the Rave EDC system (Medidata Solutions). 
  • Configures standards to the specific needs and requirements of a Therapeutic Area, compound, or Disease Area, generating the expected efficiencies through optimal adoption and reuse of standards.
  • Supports the functions adopting the standards in the clinical trials, in close collaboration with the clinical data collection team. 
  • Implements standard content in collection and delivery tools, in compliance with industry standards and health authority regulations, and meeting best practices for computer system validation, where applicable.

Examples of standard content for data collection:-Standard Case Report Form Mockups -Standard Questionnaires, Rating Scales and Clinical Outcome Assessments -Standard Validation Rule Specifications -Standard Integrations (e.g., with IWRS) 

Data delivery:

  • Annotates the CRF with SDTM metadata
  • Collaborates with team members on the correctness of the annotated CRF form, ensuring that submission, scientific and operational requirements and guidelines are met.
  • Defines and maintains the standard clinical data collection and the clinical data delivery standards for use in clinical trials. 
  • Maintains data collection & delivery and metadata standards at a master level, to meet additional scientific or operational requirements of the R&D portfolio.
  • Guarantees that formal change management control and versioning of the standards are applied and adhered to.
  • Formally governs all the changes to standards; manages multiple versions in-line with the adoption needs of trials and drug development programs. 
  • Pre-configures standards in-line with specifications of the data lifecycle plans, while maintaining the traceability and lineage of the data. 
  • Correctly documents and manages the lineage between master standards and several pre-configured standards.   
  • Provides necessary support to clinical data standards clinical analysis teams, who facilitate the consistent adoption of standards in the studies (internally or outsourced to a CRO).  
  • Collborates with cross-functional teams / departments to ensure accurate testing & QC of collection tools and mapping of metadata

Examples of standard content for data delivery:-Study Data Tabulation Model (SDTM)-Annotated Case Report Forms (CRFs)-Support the data transfer agreement (DTA) standards with SDTM-Data Review Model (DRM: internal SDTM like model)-Mapping metadata from data collection (CRF and DTA) to DRM-Mapping metadata from DRM to SDTM

Qualifications

  • BS/BA degree in life sciences or computer science or equivalent by work experience  
  • Deep expertise in Rave eDC (Medidata Solutions) 
  • Experience with running SAS programs (coding experience is preferred)
  • Expertise with CDISC standards: SDTM, CDASH, Controlled terminology and define.xml. 
  • 2+ years of relevant operational experience in clinical data management or standards
  • Experience in prioritizing and managing multiple tasks simultaneously 
  • Outstanding written and verbal communication skills in English 
  • Experience with SAS LSAF and Pinnacle 21 is a plus

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

Principal Clinical Data Standards Architect

Pharmaceutical Research Associates, Inc

US only
Apply now