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Local Trial Manager
hace 3 meses
Career CategoryClinical
Job Description
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 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. It's time for a career you can be proud of. Join us as:
LOCAL TRIAL MANAGER - REMOTE POSITION
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 execution 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 execution 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 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 lead all aspects of deliverables of study support staff and continually review country level risk mitigation to ensure study delivers to plan
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 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 Spanish language and business English
Preferred Requirements
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.)
Must be a local/country expert with proven project management experience locally
Must be able to build strong site relationships as well as other local relationships to ensure end to end study delivery is met
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, enhance 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
Amgen is committed to equal treatment, diversity and the inclusion of employees with disabilities, and is open to all. If you have a disability, do not hesitate to inform your Human Resources contact of any adaptations or tools required for the recruitment process to run smoothly. If you have any specific questions relating to your disability, please do not hesitate to ask them in confidentiality.
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R-183286
Remote/Remotely/Tele/Telecommute/From home
