Senior Clinical Data Management Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeData Full time €108,000 - €131,500
Job Overview

The Senior Clinical Data Team Lead plays a pivotal role in supporting clinical studies across all stages of drug development. Key responsibilities include contributing to data management activities, leading database build activities, and overseeing the collection, coding, and cleaning of data by vendors.

Main Responsibilities
  • Lead cross-functional review of eCRF content, edit check specifications, and user acceptance testing
  • Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
  • Oversight of database lock activities and ultimate archiving of study data
  • Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors
  • Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews
  • Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation
  • Contribute to development and implementation of department workflows and infrastructure strategy that reflects data collection standards, consistent with industry best practice and regulation
  • Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
Qualifications and Requirements

A successful candidate will possess the following qualifications:

  • Bachelor's degree in a scientific discipline
  • At least 7 years related experience in a pharmaceutical/biologics/biotechnology company
  • Experience working in clinical drug development through Phase 3 in an outsourced CRO model; experience with drug development in rare genetic diseases preferred
  • Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
  • Knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH
  • Experience working with Medidata Rave
  • Experience using standardized medical terminology, including MedDRA and WHODrug
  • Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project

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