Local Clinical Trial Manager

Local Clinical Trial Manager

Amgen

Breda, Netherlands

WHAT YOU WILL DO

The Local Trial Manager is a new role as part of our Next Generation Trial Execution Build. The goal is to optimize our clinical trial delivery from early till late studies. In this important new role you will be the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out (CSR/Archival) for the Netherlands in accordance with ICH-GCP (Good Clinical Practices) and other applicable local regulations. You will maintain the quality and scientific integrity of clinical trials at 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.

Let’s do this. Let’s change the world. In this vital role you will:

  • 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;
  • Analyze country specific study trends and implement improvement opportunities.

WHAT WE EXPECT OF YOU

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

  • Master’s degree in medical related field of study;
  • Outstanding knowledge of global clinical trial management;
  • 7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience acquired working on clinical trials in a biotech, pharmaceutical or CRO company;
  • Strong communication skills in both Dutch and English;
  • Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.);
  • Country expert with proven project management experience locally;
  • Ability to build strong site relationships as well as other local relationships to ensure end to end study delivery is met.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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