Clinical Data Strategist

1 week ago

Dublin, Dublin City, Ireland beBeeDataScientist Full time €100,000 - €140,000
Job Title: Principal Clinical Data Scientist

We are seeking an experienced professional to manage data management, coding and DAP aspects of clinical studies.

This role is a key collaborator and strategic partner with stakeholders ensuring that pharmaceutical drug development plans are executed efficiently with timely and high quality deliverables.

  • Lead functional activities for clinical studies in phase I to IV.
  • Co-ordinate activities of Data Managers either internally or externally.
  • Make data management decisions and propose strategies at study or project level.
  • Ensure application of consistent data management processes, influence increased standardization and documentation across assigned projects -Comply with industry standards and processes.
  • Provide and implement data Management solutions; ensure knowledge sharing.
  • Leads process and training deliverables within multiple platforms, franchises or therapeutic areas. Develops strategies to ensure effective training and knowledge retention.
  • Progresses towards complete, compliant, agile and simple end to end processes and effective training (Protocol/Measure through Analysis and Reporting).
  • Representative in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response.
  • Act as subject matter expert (SME) or, as assigned, lead process improvement/non clinical project initiatives.
  • Develops risk Mgmt strategies to prevent data quality/coding issues from derailing projects -Reporting of technical complaints / adverse events / special case scenarios related to products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Required Skills and Qualifications:

  • Degree/Masters qualified in a relevant area.
  • Ideally 9+ years' experience in Drug Development with at least 8 years' in Clinical Data Management.
  • Experience working across several end to end studies.
  • Strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines.
  • Excellent understanding of clinical trials methodology, GCP and medical terminology.
  • Proven ability to interrogate and view data through various programming/GUI techniques.

About Us:

Maintaining open lines of communication, staying focused on our patients, and respecting diverse perspectives while encouraging innovative solutions drives us forward. Our values inspire how we work, who we're willing to hire, and whom we want to become.

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