14 days old

Global Clinical Trial Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115030024
Amgen

Job ID: R-83472
Location: Thousand Oaks, CA, US 91360
Additional Location: US - California - South San Francisco

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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.

The Global Clinical Trial Manager is the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCP.

Responsibilities:
  • Oversee the quality and scientific integrity of clinical operations for studies at a global level
  • Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
  • Lead the Clinical Study Team to drive effective decision making
  • Plan and manage the reporting of clinical studies conducted by Global Development through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
  • Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
  • Management of study budget and timelines
  • Management of vendors to the required standards
  • 5% travel to support the execution of clinical studies


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:

Bachelor's degree

7+ years work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company

Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)

Experience of collaborating and leading cross-functional teams in a matrix environment

Experience of working internationally

Experience of managing complex projects across multiple countries and time zones

Experience of anticipating and resolving problems

Evidence of excellent interpersonal skills

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.

PI115030024

<b>Amgen</b><br/><br/><b>Job ID: </b>R-83472<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - California - South San Francisco<br/><br/>Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.<br><br>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.<br><br>The Global Clinical Trial Manager is the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCP.<br><br>Responsibilities:<br><ul><li>Oversee the quality and scientific integrity of clinical operations for studies at a global level</li><li>Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables</li><li>Lead the Clinical Study Team to drive effective decision making</li><li>Plan and manage the reporting of clinical studies conducted by Global Development through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables</li><li>Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines</li><li>Management of study budget and timelines</li><li>Management of vendors to the required standards</li><li>5% travel to support the execution of clinical studies</li></ul><br><br>Basic Qualifications:<br><br>Doctorate degree<br><br>OR<br><br>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>Bachelor's degree<br><br>7+ years work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company<br><br>Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)<br><br>Experience of collaborating and leading cross-functional teams in a matrix environment<br><br>Experience of working internationally<br><br>Experience of managing complex projects across multiple countries and time zones<br><br>Experience of anticipating and resolving problems<br><br>Evidence of excellent interpersonal skills<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/b7QOari88qwQCxEkINmMp"> <p>PI115030024</p>

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Posted: 2019-11-01 Expires: 2019-12-02

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Global Clinical Trial Manager

Amgen
Thousand Oaks, CA 91360

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