Local Trial Manager

4 meses atrás

São Paulo SP, Brasil Amgen Tempo inteiro

**Job Description**:
**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. How will you put your skills, experience and passion to work toward your goals? 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

**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 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, through leadership with engagement of the cross-functional Local Study Team
- Communicate country status (including timelines and results) 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 deliver all study support staff and continually review country level risk mitigation to ensure study delivers to plan
- Build strong site relationships as well as other local relationships to ensure end to end study delivery is met.

**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 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**:

- Educational Background Bachelor’s Degree in Life Science
- Work experience in life sciences or medical related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
- 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 (e.g., CROs, central labs, imaging vendors, etc.)
- Must be a local/country expert with identifiable project management experience locally

**Thrive**:
**What you can expect of us**

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.

**for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

Amgen 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.

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