Clinical Research Study Manager - Early Development - South San Francisco, CA | Biospace
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Clinical Research Study Manager - Early Development

Amgen

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Location:
South San Francisco, CA
Posted Date:
5/24/2017
Position Type:
Full time
Job Code:
R-38369
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

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.

Responsibilities:

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

Requirements

Basic Qualifications:

Doctorate Degree

OR

Master's Degree and 3 years of Clinical experience

OR

Bachelor's Degree and 5 years of Clinical experience

OR

Associate's degree and 10 years of Clinical experience

OR

High school diploma/GED and 12 years of Clinical experience

Preferred Qualifications:

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.