Clinical Research Study Manager - Early Development
South San Francisco
Few careers offer the chance to make a difference in people's lives. Take advantage of the opportunity at Amgen, the world's largest biotechnology company. With global manufacturing operations and clinical development sites on three continents, Amgen is focused and committed to making our products available to improve patients' lives through innovative science.
Amgen Early Development group in San Francisco, CA is looking for a Clinical Research Study Manager to support the operational strategy and design of phase 0 - 1 clinical trials and manage the operational activities related to the planning, implementation, and reporting of results in accordance with the program plans, GCP and standard operating procedures.
The Clinical Research Study Manager will work in varying therapeutic areas including oncology, cardiovascular, inflammation, neuroscience and healthy volunteer.
Responsibilities of the Clinical research Study Manager include:
Leading operational strategy, 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; Planning and 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 study concept documents, protocols, relevant sections of annual safety reports, clinical study reports, and publications; Management and/or oversight of trial 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 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.
Website : http://www.amgen.com
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses.