Career Category: Clinical
Job Description
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.
Local Trial Manager (LTM)
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 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 at a local/country level and actively collaborate with cross-functional internal and external partners to ensure timely delivery, budget, and 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.
* Plan, manage, and oversee 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.
* Provide country-level input into the Country Operational Plan and collaborate 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 delivery to plan.
Win
We are all different, yet we all use our outstanding contributions to serve patients. The qualified professional we seek is a Trial Manager with these qualifications.
Minimum Requirements
* 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.
* Advanced knowledge of global clinical trial management.
* Fluency in local language and business English.
Preferred Requirements
* BA/BS/BSc.
* Minimum 2-3 years’ experience 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.
* Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors).
* Must be a local/country expert with identifiable project management experience locally.
* Build strong site relationships and other local relationships to ensure end-to-end study delivery.
Thrive
Some of the vast rewards of working here:
* Support and career-development resources to expand your skills and potential.
* A diverse and inclusive community of belonging.
* Generous Total Rewards Plan—comprising health, finance, work/life balance, and career benefits—with high ratings on Glassdoor.
Apply now for a career that defies imagination.
Objects in your future are closer than they appear.
Join us. Careers.Amgen.Com
Amgen is an Equal Opportunity employer. We consider all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. Reasonable accommodation is available for individuals with disabilities. Please contact us to request accommodation.
Summary
Location: Spain - Barcelona
Type: Full time
El anuncio original lo puedes encontrar en Kit Empleo: https://www.kitempleo.es/empleo/212264578/local-trial-manager-gu013-barcelona/?utm_source=html
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