Global Study Lead

1 month ago


Gold Coast, Queensland, Australia Pharmiweb Full time
Job Summary

We are seeking a highly skilled Global Study Lead to join our team at ICON. As a Global Study Lead, you will be responsible for planning and leading the delivery of non-interventional studies to time, quality, budget, company standards, and scientific requirements.

Key Responsibilities
  • Plan and lead the delivery of non-interventional studies
  • Lead the study delivery team of functional subject matter experts
  • Function as the Study Accountable Person for all ICH GCP and SOP-driven activities
  • Coordinate study protocol development
  • Lead escalation and resolution of any issues with CROs/vendors/sites/country performance
  • Maintain regular interaction with all study team members to ensure issues/risks/successes with study delivery are reviewed and/or shared as they occur
  • Lead key discussions with CRO suppliers to ensure appropriate expectations have been set and CROs are aligned on delivery strategy
  • Encourage CROs to take accountability for quality data delivery
  • Provide holistic oversight of CROs - understand study contribution to program/submission
  • Accountability for study delivery strategy (e.g. country selection, diversity, patient engagement strategy etc)
  • Single point accountability for the operational delivery of clinical study to time, quality, and budget (through to completion of TMF archiving)
  • Drive assessment, selection, engagement, and management of appropriate vendors for outsourced clinical activities/services
  • Ensure inspection readiness for study at all times and overall accountability for eTMF
  • Ensure development, review, finalization, and delivery of high-quality key clinical study documents in order to meet study timelines
  • Manage internal and external stakeholders through appropriate engagement and communication
  • Provide leadership at study level to ensure accuracy, quality, and timeliness of update of operational data maintained in systems used to track studies
Requirements
  • University degree
  • Previous project management experience, ideally in managing non-interventional studies
  • Ability to lead cross-functional teams - set priorities and performance targets in a global environment
  • Creative thinker - able to modernize approach to study delivery
  • Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
  • Effective problem-solving and conflict resolution skills with a solutions-oriented mindset
  • Operational expertise in risk management and contingency planning
What We Offer

We offer a competitive salary and a range of additional benefits, including various annual leave entitlements, health insurance offerings, competitive retirement planning offerings, and a global employee assistance program.

We are committed to providing an inclusive and accessible environment for all candidates and are proud of our diverse workforce.



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