Global Site Management Lead

BioSpace

Irvine (CA)

On-site

USD 150,000 - 190,000

Full time

10 days ago
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Benefits offered by this job

Benefits package
Long-term incentives

Job summary

AbbVie is seeking an experienced Clinical Site Management leader to direct CSM integrity, timeliness, and quality across assigned studies. The role may serve as study strategy leader or manage area site execution in collaboration with other SMLs in a matrix environment.

The successful candidate will drive site monitoring strategy, engagement, and protocol adherence, ensuring TMF completeness and inspection readiness throughout the study lifecycle.

Qualifications

  • Bachelor's degree or equivalent in a (para)medical or scientific field.
  • Minimum 5 years of industry clinical research experience including 2 years of monitoring or project management on a global study.
  • Experience in study initiation through completion in multiple phases (Phase II/III).
  • Demonstrates a high level of core and technical competencies in clinical trials.
  • Excellent written and verbal communication skills in English; able to influence in a matrix environment.

Responsibilities

  • Accountable for driving study level global and/or area level CSM deliverables by timelines and resources.
  • Analyze study timelines and assumptions to confirm deliverables feasible for CSM; communicate resource needs.
  • Maintain study-level and/or area-level timelines across the lifecycle and support country-level milestone execution.
  • Oversee monitoring activities at study/area level; ensure quality and milestone adherence; manage TMF completeness for CSM artifacts.
  • Lead risk assessment and mitigation planning; collaborate with stakeholders for continuous improvement.
  • Ensure on-going CSM inspection readiness and site engagement throughout the study.

Skills

Clinical research
Leadership
Communication
Study planning
English fluency

Education

Bachelor's degree or equivalent

Tools

Microsoft Word
Microsoft PowerPoint
Microsoft Excel
Microsoft OneNote

Job description

AbbVie is seeking an experienced Clinical Site Management leader to direct CSM integrity, timeliness, and quality across assigned studies. The role may serve as study strategy leader or manage area site execution in collaboration with other SMLs in a matrix environment.

The successful candidate will drive site monitoring strategy, engagement, and protocol adherence, ensuring TMF completeness and inspection readiness throughout the study lifecycle.

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