Clinical Data Management, Manager
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Clinical Data Management, ManagerLive
What you will do
Lets do this. Lets 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
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
- Bachelors 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 (CROs, central labs, imaging vendors, etc.)
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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf 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.