Amgen Clinical Research Study Manager - Early Development in South San Francisco, California
Few careers offer the chance to make a difference in people's lives. Take advantage of the opportunity at Amgen to strategically support and oversee the design of phase 0-1 and 1b clinical trials, managing the operational activities related to the planning, implementation, and reporting of results in accordance with the program plans, GCP and standard operating procedures. Work in varying therapeutic areas including oncology, cardiovascular, inflammation, neuroscience and healthy volunteer.
Planning, management and reporting of clinical studies conducted by Early Development or the Functional Service Provider through oversight of cross-functional study activities
Identification and resolution of issues
Communication of study timelines and deliverables ensuring studies are conducted in accordance with SOPs, GCP and regulatory guidance
Contributing to the First in Human Portal document/Global Development Plan
Contributing to/authoring protocols, relevant sections of annual safety reports, clinical study reports, and publications
Management and/or oversight of study budget, timelines and insourcing/outsourcing partners to the required standards
Master's Degree and 3 years of Clinical experience
Bachelor's Degree and 5 years of Clinical experience
Associate's degree and 10 years of Clinical experience
High school diploma/GED and 12 years of Clinical experience
MS or RN
7+ years of experience in life sciences or medically related field
4+ years of bio-pharmaceutical clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials at academic institutions or working on clinical trials in a biotech, pharmaceutical or CRO company
Management experience of direct reports
Experience in oversight of Functional Service Providers, outside vendors (CRO's, central labs, imaging vendors, etc)
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, 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.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.