Clinical Trial Manager H/F
Amgen
Hauts-de-Seine
il y a 3j

Description du poste et des missions

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have.

At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide.

Become the professional you are meant to be in this meaningful role.

CLINICAL TRIAL MANAGER (LTM)

WHAT YOU WILL DO :

Let’s do this. Let’s change the world. In this vital role you will be the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out (CSR / Archival) at a country level in accordance with ICH-GCP and other applicable local regulations.

You will maintain the quality and scientific integrity of clinical trials at a local / country level and actively collaborate with cross functional internal and external partners to ensure timely delivery, budget execution of clinical trial results within the local country.

Key Activities :

  • Partner with global and local country teams to provide high level country strategy and actively drive study progress and local / country level study delivery
  • Planning, management and oversight of clinical study execution in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team
  • Communicate country status (including timelines and deliverables) to key partners including updates to relevant systems for transparency
  • Provides country level input into the Country Operational Plan and partners with the Development Feasibility Manager through feasibility and with the Global Clinical Managers to ensure local delivery of the study
  • Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., vendor management
  • Assign and lead all aspects of deliverables of study support staff and continually review country level risk mitigation to ensure study delivers to plan
  • WHAT WE EXPECT OF YOU

    We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Trial Manager with these qualifications.

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