Job Description

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you\xe2\x80\x99re part of something bigger, it\xe2\x80\x99s because you are. At Amgen our shared mission\xe2\x80\x94to serve patients\xe2\x80\x94drives all that we do. It is key to our becoming one of the world\xe2\x80\x99s leading biotechnology companies. We are global collaborators who achieve together\xe2\x80\x94researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It\xe2\x80\x99s 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 include, but not limited to:

• 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.
• Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM.

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 delivering 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 organization
• Previous experience at or oversight of outside clinical research vendors (CRO\xe2\x80\x99s, 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\xe2\x80\x99 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

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 Equal 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.