Local Trial Manager - México

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. We have proudly achieved certifications as Great Place to Work and Equidad MX. Join us and transform the lives of patients while transforming your career.

Local Trial Manager - México

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. 
• 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 deliverables) to key stakeholders 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 oversee deliverables of study support staff e.g., Study Management Associate, CTS , SASM (Snr. Assc. Study management) 
• 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 & 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 
• English – Business proficient.

Preferred Qualifications:

• 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.)  
• Local knowledge / expertise of regulatory environment, study start up process and associated timelines etc. 
• Clinical trial processes and operations  
• Extensive knowledge of ICH/GCP regulations and guidelines  
• Global to Local project management with oversight of study deliverables 
• Program management including oversight of study deliverable, budgets and timelines  
• Time, cost and quality metrics including key performance indicators (KPIs) 
• Relevant Therapeutic knowledge is preferred  

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.

Apply now

for a career that defies imagination

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

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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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.