LOCAL TRIAL MANAGER - MEXICO

Career Category Clinical Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are.
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.
We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide.
We have proudly achieve certifications as Great Place to Work and Equidad MX.
It’s time for a career you can be proud of.
Join us.
Local Trial Manager - Mexico 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.
., 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.
3 years leading local/regional or global teams experience.
3 years Clinical Trial Project Management experience.
Fluency in local language and business English.
Experience in management and oversight of external vendors (e.
., CROs, central labs, imaging vendors, etc.) Must be a local/country expert with identifiable project management experience locally.
THRIVE! Some of the vast rewards of working here 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.
Full support and career-development resources to expand your skills, improve 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor.
Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt.
Join us.
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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..
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
A biotechnology pioneer since , Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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