Clinical Trials Manager

hace 2 días


Xico, México Amgen A tiempo completo

Job Summary

We are seeking a highly skilled and experienced Clinical Trials Manager to join our team at Amgen. As a key member of our clinical operations team, you will be responsible for leading and managing the conduct of clinical trials from study start-up to close out at a country level.

Key Responsibilities

  • Partner with global and local country teams to provide high-level country strategy and drive study progress and local/country-level study delivery
  • Plan, manage, and oversee clinical study implementation in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team
  • Communicate country status, including timelines and results, to key partners and update relevant systems for transparency
  • Provide country-level input into the Country Operational Plan and partner with the Development Feasibility Manager to ensure local delivery of the study
  • Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate, such as vendor management
  • Assign and deliver all study support staff and continually review country-level risk mitigation to ensure study delivers to plan
  • Build strong site relationships as well as other local relationships to ensure end-to-end study delivery is met

Requirements

  • Doctorate degree or equivalent experience
  • Master's degree with 3 years of clinical trials experience or equivalent
  • Bachelor's degree with 5 years of clinical trials experience or equivalent
  • Associate's degree with 10 years of clinical trials experience or equivalent
  • High school diploma/GED with 12 years of clinical trials experience or equivalent

Preferred Requirements

  • Educational background in life sciences or medical-related field, including biopharmaceutical clinical research experience
  • 2 years of leading local/regional or global teams experience
  • 2 years of clinical trial project management experience
  • Fluency in local language and business English
  • Experience in management and oversight of external vendors, such as CROs, central labs, imaging vendors, etc.
  • Must be a local/country expert with identifiable project management experience locally


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