Career Category

Job Description

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

LIVE

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.

WIN

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

THRIVE

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

APPLY NOW

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.

careers.amgen.com