Clinical Trial Manager
4 semanas atrás
Key Responsibilities:
As a Clinical Trial Manager at Amgen Sa, you will be responsible for leading and managing the conduct of clinical trials from study start-up to close out at a country level. This includes maintaining the quality and scientific integrity of clinical trials, collaborating with cross-functional internal and external partners, and ensuring timely delivery and 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 drive study progress and local/country level study delivery.
Plan, manage, and oversee 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 and update relevant systems for transparency.
Provide country level input into the Country Operational Plan and partner 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.
Requirements:
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 Portuguese 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.
About Amgen Sa:
At Amgen Sa, our shared mission is to serve patients. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. We offer a diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act. We provide full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey. We are committed to equal treatment, diversity, and the inclusion of employees with disabilities, and are open to all. If you have a disability, do not hesitate to inform your Human Resources contact of any adaptations or tools required for the recruitment process to run smoothly.
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