Amgen Clinical Data Management Manager in Uxbridge, United Kingdom
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
CLINICAL DATA MANAGEMENT MANAGER
What you will do
In this vital role you will responsible for ensuring clinical projects are executed according to set timelines with quality and consistency. The successful candidate may be responsible for one or multiple products depending on the complexity.
You will be responsible to ensure that Data Management (DM) procedures and processes are adhered to by vendor staff through oversight of quality, cycle times, metrics and use the Issue CAPA process. Key responsibilities:
Training and mentoring of DM TA staff on processes, projects and programmes
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 development of DM outsourcing strategies and long-term relationships with CRO partners / external vendors
Oversight of FSP vendors with respect to quality, Issue & CAPA tracker & KPI metrics
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:
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
Actively monitor progress of clinical projects within assigned product area to ensure delivery to set timelines and quality standards
Provide DM product level input to developing and managing resource plans and budgets for DM
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
Be part of our team
You would be joining Clinical Data Management, a global team which predominantly operates from Uxbridge and Cambridge in the UK; as well as Thousand Oaks and San Francisco in the US. The team is part of Global Study Operations which comprises both Data Management and Site Management. We all work together to meet the demands of an industry-leading, fast paced organization, with a commitment to innovation and quality in all that we do; whilst executing clinical trials and serving our patients.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
Bachelors degree or equivalent in life science, computer science, business administration or related discipline
Broad and proven experience in life sciences or a medically related field including experience in biopharmaceutical clinical research experience
Extensive Data Management experience in a global organisation
Previous experience at or oversight of outside clinical research vendors (CRO’s, central Labs, vendors, etc..)
Knowledge of Good Clinical Practice, Drug development and clinical trials processes, clinical trial databases and applications, Quality Management, Regulatory filings and inspections, Risks analysis, Process improvement methodologies is essential
What you can expect of us
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.
Vast opportunities to learn and move up and across our global organization
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
Location: Cambridge or Uxbridge with flexibility to work from home
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. 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.