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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Clinical Data Management, Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will achieve results through goal setting, accountability measures, effective teamwork, performance management, collaboration with other groups. Ensure a focus on timely quality delivery, as well as consistency across the Data Manager components.

• Train and mentor 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
• Contribute to the continuous improvement of DM and the wider Development organization through information sharing, training and education
• Development of DM outsourcing strategies and long-term relationships with CRO partners / external vendors
• Promote and be an advocate of DM internally and externally and represent DM at project team meetings i.e., GCST
• Project level coordination of and day to day oversight of DM tasks including: Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines, and 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 and lead vendor results and relationship at the project level
• Communication 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 and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Clinical professional we seek is an analytical leaser with these qualifications.

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 field
• 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.)

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

(Location Options: Remote and On-site)

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com