1+ months

Clinical Data Management, Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    118538186
Amgen

Job ID: R-94515
Location: Thousand Oaks, CA, US 91360
Additional Location: US - California - South San Francisco

The GSO-Data Management (DM), Manager (Project Lead) role will partner with cross functional study team as well as our functional service provider (FSP) to ensure product delivery of the Amgen Therapeutic Area (TA) portfolio. This individual achieves results through rigorous goal setting, accountability measures, effective teamwork, performance management, collaboration with other groups and a commitment to serving customers both inside and outside of Global Study Operations (GSO).

This individual will ensure a focus on timely quality delivery as well as consistency across the Data Manager components. All results will be achieved in a manner that embodies Amgen culture and values; collaboration and teamwork, ethics, and staff development.

Responsibilities:
  • Training and mentoring of DM TA staff on processes, projects and programs
  • Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM
  • Participate in and/or lead DM and cross functional working groups
  • Contribute to the continuous improvement of DM and the wider Development organization through information sharing, training and education
  • Contribute to development of DM outsourcing strategies and long-term relationships with CRO partners / external vendors
  • Promote and be an advocate of DM internally and externally
  • Represent DM at project team meetings i.e., Global Clinical Study Team (GCST)
  • Project level coordination of and day to day oversight of DM tasks including:
  • Co-ordination of lead DM's within the project
  • Review of all DM documents within a project area to ensure a consistent approach
  • Overview of project timelines and metrics to ensure databases are delivered to set timelines
  • Approve database locks and unlocks
  • Ensure that quality control checks are occurring such that quality databases are delivered
  • Develop and co-ordinate project level training for data management staff
  • Review and approve study specific training
  • Manage vendor deliverables and relationship at the project level
  • Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
  • Review of all study level non DM documents for awareness and project level consistency
  • Lead electronic submission activities
  • Assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level


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 in life science, computer science, business administration or related discipline

6+ years work experience in data management in the Pharmaceutical or Biotech arena

3+ years project management and planning experience

Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, etc.)

Leadership Skills

The GSO DM Manager - Project Lead will be a highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in a multi-project, high-pressure environment. This role will have extensive clinical trial experience and leadership expertise. He or she will be a strategic & driven leader who will identify and implement opportunities, be passionate about improving efficiencies and gain consistency across DM delivery processes. With strong negotiation skills; he or she will be able to address conflict head-on and facilitate rapid resolution.

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.

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.

PI118538186

<b>Amgen</b><br/><br/><b>Job ID: </b>R-94515<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - California - South San Francisco<br/><br/>The GSO-Data Management (DM), Manager (Project Lead) role will partner with cross functional study team as well as our functional service provider (FSP) to ensure product delivery of the Amgen Therapeutic Area (TA) portfolio. This individual achieves results through rigorous goal setting, accountability measures, effective teamwork, performance management, collaboration with other groups and a commitment to serving customers both inside and outside of Global Study Operations (GSO).<br><br>This individual will ensure a focus on timely quality delivery as well as consistency across the Data Manager components. All results will be achieved in a manner that embodies Amgen culture and values; collaboration and teamwork, ethics, and staff development.<br><br>Responsibilities:<br><ul><li>Training and mentoring of DM TA staff on processes, projects and programs</li><li>Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM</li><li>Participate in and/or lead DM and cross functional working groups</li><li>Contribute to the continuous improvement of DM and the wider Development organization through information sharing, training and education</li><li>Contribute to development of DM outsourcing strategies and long-term relationships with CRO partners / external vendors</li><li>Promote and be an advocate of DM internally and externally</li><li>Represent DM at project team meetings i.e., Global Clinical Study Team (GCST)</li><li>Project level coordination of and day to day oversight of DM tasks including:</li><li>Co-ordination of lead DM's within the project</li><li>Review of all DM documents within a project area to ensure a consistent approach</li><li>Overview of project timelines and metrics to ensure databases are delivered to set timelines</li><li>Approve database locks and unlocks</li><li>Ensure that quality control checks are occurring such that quality databases are delivered</li><li>Develop and co-ordinate project level training for data management staff</li><li>Review and approve study specific training</li><li>Manage vendor deliverables and relationship at the project level</li><li>Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.</li><li>Review of all study level non DM documents for awareness and project level consistency</li><li>Lead electronic submission activities</li><li>Assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level</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 in life science, computer science, business administration or related discipline<br><br>6+ years work experience in data management in the Pharmaceutical or Biotech arena<br><br>3+ years project management and planning experience<br><br>Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, etc.)<br><br>Leadership Skills<br><br>The GSO DM Manager - Project Lead will be a highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in a multi-project, high-pressure environment. This role will have extensive clinical trial experience and leadership expertise. He or she will be a strategic & driven leader who will identify and implement opportunities, be passionate about improving efficiencies and gain consistency across DM delivery processes. With strong negotiation skills; he or she will be able to address conflict head-on and facilitate rapid resolution.<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>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/8OdZzrtoj624hEVNhwkaB"> <p>PI118538186</p>
Posted: 2020-02-29 Expires: 2020-03-31

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Clinical Data Management, Manager

Amgen
Thousand Oaks, CA 91360

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