Clinical Trial Manager
hace 2 semanas
About Amgen Sa
At Amgen Sa, our mission is to serve patients by developing innovative treatments that improve lives. As a global biotechnology company, we collaborate with experts from around the world to research, manufacture, and deliver life-changing products that reach millions of patients worldwide.
Job Summary
We are seeking a highly skilled Clinical Trial Manager to lead the conduct of clinical trials from start-up to close-out at a country level. As the primary point of contact, you will be responsible for maintaining the quality and scientific integrity of clinical trials, collaborating with cross-functional teams, and ensuring timely delivery of clinical trial results within the local country.
Key Responsibilities
- 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, leading 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 collaborate with the Development Feasibility Manager to ensure local delivery of the study.
- Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate, such as vendor management.
- Assign and lead all aspects of deliverables of study support staff and continually review country-level risk mitigation to ensure study delivery to plan.
Requirements
- Doctorate degree or Master's degree with 3 years of directly related experience or Bachelor's degree with 5 years of directly related experience or Associate's degree with 10 years of directly related experience or High school diploma/GED with 12 years of directly related experience.
- Advanced knowledge of global clinical trial management.
- Fluency in Spanish 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.
What We Offer
- 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.
Amgen Sa is an Equal Opportunity Employer
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