Local Trial Manager
4 semanas atrás
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Local Trial Manager - Brazil
What you will doIn this vital role, you will be the primary point of contact to lead, manage, and coordinate 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 and actively collaborate with cross-functional internal and external partners to ensure timely delivery and budget implementation 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 implementation in accordance with the global program strategy.
- Communicate country status (including timelines and results) to key partners.
- Provide country-level input into the Country Operational Plan and partner with the Development Feasibility Manager.
- Support internal audit and inspection activities and contribute to CAPAs.
- Assign and deliver all study support staff and continually review country level risk mitigation.
- Build strong site relationships to ensure end-to-end study delivery is met.
The qualified professional we seek is a Local Trial Manager with these qualifications.
Basic Qualifications:
- Doctorate degree
- OR Master’s degree & 2 years of Clinical Trials experience
- OR Bachelor’s degree & 4 years of Clinical Trials experience
- OR Associate’s degree & 8 years of Clinical Trials experience
- OR High school diploma / GED & 10 years of Clinical Trials experience
Preferred Qualifications:
- Bachelor’s Degree in Life Science
- Work experience in life sciences or medical related field, including biopharmaceutical clinical research experience
- 2 years leading local/regional or global teams experience
- 2 years Clinical Trial Project Management experience
- Fluency in local language and business English
- Experience in management and oversight of external vendors.
- Must be a local/country expert with identifiable project management experience.
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. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now for a career that defies imaginationObjects in your future are closer than they appear. Join us.
careers.amgen.comAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process.
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