Global Clinical Trial Coordinator
3 semanas atrás
As a key member of our team at Amgen Sa, you will play a pivotal role in leading, managing, and coordinating 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.
Key Responsibilities:
- 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.
- 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:
- 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:
Amgen Sa is committed to equal treatment, diversity, and the inclusion of employees with disabilities, and is 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.
Amgen Sa is an equal opportunities employer.
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