Clinical Trial Manager

Patients. For them, we research, develop and manufacture innovative therapies for serious diseases, using living resources. This approach is based on cutting-edge technologies, such as human genetics, which enable us to characterise the molecular mechanisms at the root of diseases. Amgen focuses its research on diseases for which there is still a significant medical need. With 18 drugs and numerous partnership initiatives, Amgen is working to advance the treatment of cancer, cardiovascular, inflammatory and renal diseases, as well as osteoporosis. With 54 active studies involving 964 patients in 294 centres (2022 figures), France is also one of the countries where Amgen has the largest clinical research activity. Committed to research and to patients, Amgen is just as committed to its employees Because we believe in a world where everyone can be themselves and play a role, Amgen France is socially committed through its Corporate Social Responsibility programme. In 2021, Amgen signed its first LGBT+ charter and the following year was awarded the "Very High Health, Social and Environmental Quality" label, making Amgen France the first pharmaceutical company to be awarded this label. We are also proud to have recently signed the Cancer and Employment charter to help our employees affected by the disease to remain in work and return to work. **CLINICAL TRIAL MANAGER** **LIVE**: **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 **WIN** **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. **Minimum Requirements**: - Doctorate degree OR - Master’s degree & 3 years of directly related experience OR - Bachelor’s degree & 5 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience - Advanced knowledge of global clinical trial management - Fluency in local language and business English **Preferred Requirements**: - BA/BS/BSc - Minimum 2-3 years’ experience of leading local/regional or global teams - Minimum 2-3 years’ clinical trial project management experience - 7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company - Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.) - Must be a local/country expert with proven project management experience locally - Must be able to build strong site relationships as well as other local relationships to ensure end to end study delivery is met. **THRIVE**: **Some of the vast rewards of working here** As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. - Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey - A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act - Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and bene