26 days old

Clinical Research Study Manager - Early Development

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117640184
Amgen

Job ID: R-91417
Location: Thousand Oaks, CA, US 91360

Few careers offer the chance to create 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's Early Development group is looking for a Clinical Research Study Manager to support the design of phase 0-1 and 1b clinical trials and be responsible for the operational activities related to the planning, implementation, and reporting of results in accordance with the program plans, GCP and standard operating procedures.

The Study Manager will work in varying therapeutic areas including oncology, cardiovascular, inflammation, neuroscience and healthy volunteer.

Responsibilities:
  • Plan and run 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
  • Ensure studies are conducted with SOPs, GCP and regulatory guidance
  • Contribute to the First in Human Portal document/Global Development Plan
  • Contribute to/authoring protocols, significant 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 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:

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)

Regularly recognized as one of the "Best Places to Work," Amgen now has a presence in nearly 100 countries, allowing us to reach millions of people in their fight against serious, life-interrupting illnesses. A values-based organization, Amgen takes great pride in our ability to touch so many lives as we uphold our mission: to serve patients.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

PI117640184

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91417<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Few careers offer the chance to create 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.<br><br>Amgen's Early Development group is looking for a Clinical Research Study Manager to support the design of phase 0-1 and 1b clinical trials and be responsible for the operational activities related to the planning, implementation, and reporting of results in accordance with the program plans, GCP and standard operating procedures.<br><br>The Study Manager will work in varying therapeutic areas including oncology, cardiovascular, inflammation, neuroscience and healthy volunteer.<br><br>Responsibilities:<br><ul><li>Plan and run clinical studies conducted by Early Development or the Functional Service Provider through oversight of cross-functional study activities</li><li>Identification and resolution of issues</li><li>Communication of study timelines and deliverables</li><li>Ensure studies are conducted with SOPs, GCP and regulatory guidance</li><li>Contribute to the First in Human Portal document/Global Development Plan</li><li>Contribute to/authoring protocols, significant sections of annual safety reports, clinical study reports, and publications</li><li>Management and/or oversight of study budget, timelines and insourcing/outsourcing partners to the required standards</li></ul><br><br>Basic Qualifications:<br><br>Doctorate Degree OR Master's Degree and 3 years of Clinical experience<br><br>OR<br><br>Bachelor's Degree and 5 years of Clinical experience<br><br>OR<br><br>Associate's degree and 10 years of Clinical experience<br><br>OR<br><br>High school diploma/GED and 12 years of Clinical experience<br><br>Preferred Qualifications:<br><br>BA/BS/BSc or RN<br><br>7+ years experience in life sciences or medically related field<br><br>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<br><br>Experience in oversight of Functional Service Providers, outside vendors (CRO's, central labs, imaging vendors, etc)<br><br>Regularly recognized as one of the "Best Places to Work," Amgen now has a presence in nearly 100 countries, allowing us to reach millions of people in their fight against serious, life-interrupting illnesses. A values-based organization, Amgen takes great pride in our ability to touch so many lives as we uphold our mission: to serve patients.<br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/1wQlX5I5yxgguAprUM52z"> <p>PI117640184</p>

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Posted: 2020-01-31 Expires: 2020-03-02

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Clinical Research Study Manager - Early Development

Amgen
Thousand Oaks, CA 91360

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