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Clinical Data Systems Lead

1 month ago

Chicago, Illinois, United States AbbVie Full time
Job Title: Clinical Data Systems Lead

AbbVie is seeking a Clinical Data Systems Lead to join our Data Strategy and Operations team. As a key member of our team, you will be responsible for developing a deep understanding of clinical technologies and supporting the delivery of clinical technologies for a given program or therapeutic area.

Key Responsibilities:

  • Develop a deep understanding of clinical technologies and data flow
  • Support the delivery of clinical technologies for a given program or therapeutic area
  • Track and analyze system timelines and metrics to ensure adherence to project plans
  • Develop actionable reports and presentations for stakeholders and senior leadership
  • Collaborate with internal and external stakeholders, including system leads, data management team, clinical teams, and vendors
  • Contribute to the strategic development of clinical technology initiatives and lead the implementation as the tech project manager
  • Maintain technical knowledge of clinical data systems (EDC, IRT, eCOA, CDR, and Imaging) and understand how the capability contributes to the submission data flow and overall DSS technology strategy
  • Mentor Clinical Data Strategy and Operations Associates
  • Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and functional quality standards
  • Act as the clinical data systems SME during regulatory inspections and internal quality audits

Qualifications:

  • Bachelor's degree in business, management information systems, computer science, life sciences, engineering, or equivalent (Master's preferred)
  • 4+ years of pharmaceutical, clinical research, data management, healthcare technology experience
  • Familiar with clinical trial process and clinical technology
  • Familiar with CDASH and SDTM Standards
  • Demonstrated leadership traits and ability to influence without authority
  • Demonstrated effective project management and communication skills
  • Demonstrated effective problem-solving and analytical skills

Additional Information:

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.