Amgen

At Amgen, we believe in a “biology first” approach. We use cutting-edge science and technology to study the subtlest biological mechanisms in search of therapies that will improve the lives of those who suffer from serious diseases. Amgen believes the cure for disease can be found inside each and every one of us.

Amgen Cambridge, UK
01/02/2020
Full time
Manager - Clinical Data Management Amgen Clinical Data Management team are looking for an experienced Manager. If you are looking for your next career step within the Clinical Data Management field and want to be part of our mission – To serve patients – which drives all that we do, apply or get in touch. Take a look at our career pages to find out more about Amgen UK https://careers.amgen.com/where-we-are/en-gb/ Your Role: Working within a global team, as the Clinical Data Management Manager you are responsible for ensuring clinical projects are executed according to set timelines with quality and consistency. You may be responsible for one or multiple products depending on the complexity. You will ensure that DM procedures and processes are adhered to by vendor staff through oversight of quality, cycle times, metrics and use the Issue CAPA process. Your 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 the continuous improvement of DM and the wider Development organization through information sharing, training and education. 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., 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. Ensure that quality control checks are occurring such that quality databases are delivered. Review and approve study specific training. Manage vendor deliverables and relationship at the project level. 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. Basic Qualifications and preferred experience: 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. Location:   Cambridge or Uxbridge Remuneration:   Competitive salary & comprehensive benefits package including bonus scheme About our company: Amgen is one of the world’s largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, we have invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. 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