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Clinical Trials Manager

2 meses atrás

São Paulo, São Paulo, Brasil Amgen Tempo inteiro
Job Summary

We are seeking a highly skilled 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 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
  • Minimum 3 years of clinical trials experience, with a strong background in clinical operations and project management
  • Excellent communication and leadership skills, with the ability to work effectively in a cross-functional team environment
  • Fluency in local language and business English
  • Experience in management and oversight of external vendors, such as CROs, central labs, and imaging vendors
Preferred Qualifications
  • Bachelor's degree in Life Science or related field
  • Work experience 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
About Amgen

Amgen is a biotechnology pioneer that discovers, develops, and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis, and other serious illnesses. We are committed to improving the quality of life for people around the world and fostering an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other but compete intensely to win.