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Clinical Data Management Manager
at Amgen Inc.
Clinical Data Management Manager
Working within a global tea, Clinical Data Management Manager is 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.
The Clinical Data Management Manager 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
- 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, Uxbridge
Competitive salary & comprehensive benefits package including bonus scheme
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, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
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..
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.