Clinical Research Study Manager – Early Development
Location:
South San Francisco , California
Posted:
February 07, 2017
Reference:
R-23936
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 is looking for a Clinical Research Study Manager to support the design of phase 0-1 and 1b 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 include: 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.
Basic Qualifications:
Doctorate Degree OR Master's Degree & 3 years of Clinical experience
OR
Bachelor's Degree & 5 years of Clinical experience
OR
Associate's degree & 10 years of Clinical experience
OR
High school diploma/GED & 12 years of Clinical experience
Preferred Qualifications:
BA/BS/BSc or RN
7+ years 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.


A little about us:
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