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Senior Data Operations Programmer

2 months ago

Hounslow, Greater London, United Kingdom Pharmiweb Full time
About the Role

We are seeking a highly skilled Senior Data Operations Programmer to join our team at Pharmiweb. As a key member of our Data Operations team, you will play a critical role in supporting our clients in the pharmaceutical industry.

Key Responsibilities
  • Perform senior review of database specification documents created by study teams, including eCRF specifications and Data Review Convention specifications.
  • Build clinical study database CRF database screens per CRF/database specifications provided by the study team.
  • Create/Program edit checks, special action and derivations as per the Data Review Convention specifications.
  • Ensure non-eCRF technologies for data capture (e.g., ePRO, coding, IWRS/RTSM) are deployed as per requirements, including integrations with other systems, platforms or reporting environments with timelines for consumable data outlined.
  • Work closely with the study team to ensure all programming issues are resolved in a timely manner.
  • Complete study database updates as specified per database modification documents and procedures.
  • Trouble-shoot, solve study-building issues, and edit check-programming issues.
  • Configure and program additional system features, as required.
  • Create advanced custom programs as per Data Review Convention specifications as required.
  • Program reports and listings and contribute to the standardization of process and reports used for data review and analysis for external partners/vendors.
  • Perform senior review of critical document/deliverable (CDASH eCRFs, SDTM Annotation, SDTM datasets) to ensure Data Standards are used consistently and support creation of the eCRF.
  • Lead the development and maintenance of CDASH compliant global eCRF libraries ensuring efficient mapping to current SDTM standards.
  • Lead the development, update and retiral of CDASH compliant therapeutic area eCRF libraries ensuring efficient mapping to current SDTM standards.
  • Work as part of a study team to produce quality data.
  • Take responsibility for data operations programming deliverables within reporting teams for complex studies.
  • Work independently as a database lead builder.
  • Support data operations study teams with archiving of study documentation: archiving trial databases.
  • Lead database build teams for projects of significant complexity to ensure quality and timely deliveries on Pharmiweb projects or client studies.
  • Lead the implementation, accreditation and validation tasks for new software required to conduct Data Operations tasks.
  • Perform risk and impact assessment of new releases to software and provide input into change management plans.
  • Liaise with stakeholders to ensure successful project delivery.
Requirements
  • Life Science degree, nursing qualification or equivalent experience.
  • Experience within a CRO setting or the pharmaceutical industry to have a good awareness of clinical trial issues, design and implementation, GCP and regulatory requirements.
  • Must have experience in Veeva CDB/CDM and Medidata Rave.
  • CQL experience.
  • Inform DMW experience (desirable).