15 days old

Clinical Application and Analytical Services Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    114924456
Amgen

Job ID: R-86249
Location: Thousand Oaks, CA, US 91360
Additional Location: United Kingdom - Cambridge, United Kingdom - Uxbridge

Clinical Systems Analytical Reporting (CSAR)- Analytics team within Global Development Operations drives critical and analytical, the team enables decision making by providing insightful analytics and business intellect formed through strong business partnerships and data intelligence.

The Clinical App & Analytical Services Manager's primary focus will be to advance analytical reporting and services across Global Development Operations and foster business process expertise to provide insightful, data correlations and data intelligence, which will drive forward decision-making and monitor expected performance.

Responsibilities:

  • Effectively partner with cross-functional team members, by guiding discussions on optimized methods for data collection, standardization, governance, and reporting in order to develop innovative, analytical solutions
  • Drive forward improvement projects which interface with Informatics and Analytics across development through active vendor oversight, the Analytics Operations Lead will be responsible for direct management and oversight of vendor services, ensuring quality and timeliness of vendor product delivery.
  • Provide insights, business intelligence, and management analytics for effective decision making in alignment with Global Networks and Continuous Improvement strategies
  • Leverage BPO contacts to champion reporting needs which align to business practices and seek opportunities to drive change
  • Support study team activities, operating review meetings, and management requests through the delivery of information to support performance progress
  • Prioritize business needs and manage expectations for deliverables and exude transparency to development plans
  • Grow knowledge for how business processes, systems and reports work together to support business decisions
  • Streamline efficient and effective methods for business process automation
  • Perform quality oversight including quality gate controls validating deployment releases
  • Plan, track, and ensure execution of products and services via Functions Service Providers (FSPs)
  • Provide direct and routine timeline management while providing regular updates back to the requester(s)
  • Collaborate with interfacing technical teams including Data Management Systems and Information Systems to identify report(s) dependencies, engineer design solutions, and orchestrate deliverables towards a common goal
  • Prepare anticipated refreshed metric cycles, while analyzing data variances and trending to explain delta's or deviations in partnership with business owner


Basic Qualifications:

Doctorate degree
OR
Master's degree and 3 years of Scientific or Clinical experience
OR
Bachelor's degree and 5 years of Scientific or Clinical experience
OR
Associate's degree and 10 years of Scientific or Clinical experience
OR
High school diploma / GED and 12 years of Scientific or Clinical experience

Preferred Qualifications:
  • Solid work experience in life sciences or medically related field, including biopharmaceutical clinical product development (clinical research or clinical operations experience obtained at a biotech, pharmaceutical or CRO company)
  • Strong understanding of the concepts of clinical research and drug development
  • Strong understanding and experience in the use of performance management techniques, measurement and visualization- especially in Spotfire
  • Working experience in implementing Predictive Analytics and Machine learning models
  • Strong understanding of principals of customer service as it applies to internal and external customers
  • Advanced computer and system operation skills
  • Continuous improvement principles and their application e.g., Six Sigma
  • Understanding of project management software
  • Good organizational and planning skills
  • Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
  • Familiar with other Data Management systems (IVR, EDC, CTMS etc.)


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.

PI114924456

<b>Amgen</b><br/><br/><b>Job ID: </b>R-86249<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>United Kingdom - Cambridge, United Kingdom - Uxbridge<br/><br/>Clinical Systems Analytical Reporting (CSAR)- Analytics team within Global Development Operations drives critical and analytical, the team enables decision making by providing insightful analytics and business intellect formed through strong business partnerships and data intelligence.<br><br>The Clinical App & Analytical Services Manager's primary focus will be to advance analytical reporting and services across Global Development Operations and foster business process expertise to provide insightful, data correlations and data intelligence, which will drive forward decision-making and monitor expected performance.<br><br>Responsibilities: <br><br><ul><li>Effectively partner with cross-functional team members, by guiding discussions on optimized methods for data collection, standardization, governance, and reporting in order to develop innovative, analytical solutions</li><li>Drive forward improvement projects which interface with Informatics and Analytics across development through active vendor oversight, the Analytics Operations Lead will be responsible for direct management and oversight of vendor services, ensuring quality and timeliness of vendor product delivery.</li><li>Provide insights, business intelligence, and management analytics for effective decision making in alignment with Global Networks and Continuous Improvement strategies</li><li>Leverage BPO contacts to champion reporting needs which align to business practices and seek opportunities to drive change</li><li>Support study team activities, operating review meetings, and management requests through the delivery of information to support performance progress</li><li>Prioritize business needs and manage expectations for deliverables and exude transparency to development plans</li><li>Grow knowledge for how business processes, systems and reports work together to support business decisions</li><li>Streamline efficient and effective methods for business process automation</li><li>Perform quality oversight including quality gate controls validating deployment releases</li><li>Plan, track, and ensure execution of products and services via Functions Service Providers (FSPs)</li><li>Provide direct and routine timeline management while providing regular updates back to the requester(s)</li><li>Collaborate with interfacing technical teams including Data Management Systems and Information Systems to identify report(s) dependencies, engineer design solutions, and orchestrate deliverables towards a common goal</li><li>Prepare anticipated refreshed metric cycles, while analyzing data variances and trending to explain delta's or deviations in partnership with business owner</li></ul><br><br>Basic Qualifications:<br><br>Doctorate degree<br>OR<br>Master's degree and 3 years of Scientific or Clinical experience<br>OR<br>Bachelor's degree and 5 years of Scientific or Clinical experience<br>OR<br>Associate's degree and 10 years of Scientific or Clinical experience<br>OR<br>High school diploma / GED and 12 years of Scientific or Clinical experience<br><br>Preferred Qualifications:<br><ul><li>Solid work experience in life sciences or medically related field, including biopharmaceutical clinical product development (clinical research or clinical operations experience obtained at a biotech, pharmaceutical or CRO company)</li><li>Strong understanding of the concepts of clinical research and drug development</li><li>Strong understanding and experience in the use of performance management techniques, measurement and visualization- especially in Spotfire </li><li>Working experience in implementing Predictive Analytics and Machine learning models</li><li>Strong understanding of principals of customer service as it applies to internal and external customers</li><li>Advanced computer and system operation skills</li><li>Continuous improvement principles and their application e.g., Six Sigma</li><li>Understanding of project management software</li><li>Good organizational and planning skills</li><li>Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements</li><li>Familiar with other Data Management systems (IVR, EDC, CTMS etc.)</li></ul><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/G72oQmS1gJzWCpLZiqmY6"> <p>PI114924456</p>

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Posted: 2019-10-29 Expires: 2019-11-29

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Clinical Application and Analytical Services Manager

Amgen
Thousand Oaks, CA 91360

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