30 days old

Clinical Data Mgmt Sr Mgr

Amgen
Thousand Oaks, CA 91360
  • Job Code
    118753032
Amgen

Job ID: R-94822
Location: Thousand Oaks, CA, US 91360

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen is searching for a Clinical Data Management Senior Manager to manage Clinical Data Management (CDM) activities within and across projects within the biosimilars operational unit. This role will conduct CDM function and system integrations at Amgen and CROs/external partners to ensure timely study data delivery.

Responsible for:

  • Management of biosimilars CDM activities and program(s), including system infrastructure and integration
  • Input into group goals and objectives
  • Implementing CDM strategies and assisting in implementation of wider biosimilar goals and strategies
  • Assisting with development of, reviewing, implementing and enforcing biosimilars SOPs (Standard Operating Procedures)
  • Ensuring delivery of quality clinical trial data, within agreed upon timelines
  • Ensuring CDM processes/systems meet regulatory and business requirements
  • Assist with CRO contracts and budgets


Basic Qualifications

Doctorate degree & 2 years of Data Management experience

OR

Master's degree & 6 years of Data Management experience

OR

Bachelor's degree & 8 years of Data Management experience

OR

Associate's degree and 10 years of Data Management experience

OR

High school diploma / GED and 12 years of Data Management experience

Preferred Qualifications

Masters degree or equivalent in life science, computer science, business administration or related discipline

10 years work experience in data management in the Pharmaceutical or Biotech arena

3+ years experience in a global organization

Previous experience at or oversight of outside clinical research vendors (CRO's, central labs, imaging vendors, etc)

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.

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment. 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.

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.

PI118753032

<b>Amgen</b><br/><br/><b>Job ID: </b>R-94822<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.<br><br>Amgen is searching for a Clinical Data Management Senior Manager to manage Clinical Data Management (CDM) activities within and across projects within the biosimilars operational unit. This role will conduct CDM function and system integrations at Amgen and CROs/external partners to ensure timely study data delivery.<br><br><b>Responsible for:</b><br><br><ul><li>Management of biosimilars CDM activities and program(s), including system infrastructure and integration</li><li>Input into group goals and objectives</li><li>Implementing CDM strategies and assisting in implementation of wider biosimilar goals and strategies</li><li>Assisting with development of, reviewing, implementing and enforcing biosimilars SOPs (Standard Operating Procedures)</li><li>Ensuring delivery of quality clinical trial data, within agreed upon timelines</li><li>Ensuring CDM processes/systems meet regulatory and business requirements</li><li>Assist with CRO contracts and budgets</li></ul><br><br><b><b>Basic Qualifications</b></b><br><br>Doctorate degree & 2 years of Data Management experience<br><br>OR<br><br>Master's degree & 6 years of Data Management experience<br><br>OR<br><br>Bachelor's degree & 8 years of Data Management experience<br><br>OR<br><br>Associate's degree and 10 years of Data Management experience<br><br>OR<br><br>High school diploma / GED and 12 years of Data Management experience<br><br><b><b>Preferred Qualifications</b></b><br><br>Masters degree or equivalent in life science, computer science, business administration or related discipline<br><br>10 years work experience in data management in the Pharmaceutical or Biotech arena<br><br>3+ years experience in a global organization<br><br>Previous experience at or oversight of outside clinical research vendors (CRO's, central labs, imaging vendors, etc)<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>We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment. 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>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/oz4zXGIqExGDI6d4ulX6R"> <p>PI118753032</p>

Categories

Posted: 2020-03-05 Expires: 2020-04-05

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Clinical Data Mgmt Sr Mgr

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast