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Regional Clinical Trial Lead

hace 1 semana

Santiago, Metropolitana, Chile Alimentiv Inc A tiempo completo
Job Overview
\

Alimentiv Inc is seeking an experienced professional to lead country or regional clinical trial operations and support corporate functions as necessary.

The successful candidate will be responsible for the planning, start-up, and management of clinical trials within a defined country or region in collaboration with the global project team.

Key responsibilities include developing and maintaining professional relationships with key Investigators and thought leaders, collecting and providing insights on GI healthcare processes and drug coverage, acting as vendor lead, and overseeing regulatory compliance.

\Responsibilities
\
  • Country or Regional Operations (30%):
  • Develop and maintain professional relationships with country or regional key Investigators and thought leaders.
  • Collect and provide country/region insights on GI healthcare processes and drug coverage for GI diseases.
  • Act as vendor lead and oversee country or regional vendors (e.g., local supply depot).
  • Lead general or study-specific site qualification, feasibility, and selection activities in collaboration with the global team.
  • Support corporate operations functions as required (finance, HR, IT, legal).
  • Lead country regulatory gap assessment to ensure Alimentiv processes are in compliance with local requirements.
  • Act as Alimentiv's spokesperson in the country/region.
  • People Operations (50%):
  • Responsible for country or regional oversight of all trial activities to ensure projects are delivered in accordance with the scope of work, and ensure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.
  • Lead country or regional regulatory and/or ethics submissions for clinical trials.
  • Lead import/export processes for clinical trial materials, including investigational product(s), devices, biological samples, laboratory kits, and other materials.
  • Perform vendor management oversight as required per project.
  • Support CRA oversight, assessment, and/or training as required.
  • Contribute to financial project management processes, including input on revenue recognition, site payments, and site pass-through expense review.
  • May provide direct oversight of investigator sites, including CRA responsibilities, from time to time.
  • Communications (20%):
  • Lead and/or attend meetings with Study Sponsor.
  • May take part in or lead departmental/company improvement initiatives, committees, working streams, and governance.