Clinical Data Management Manager
United Kingdom - Cambridgeshire
Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.Career Category
ClinicalJob 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 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:
- Degree educated 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’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: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
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.
.* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Tags: Computer Science Data management Finance Research
Perks/benefits: Career development Health care Home office stipend
More jobs like this
Explore more AI, ML, Data Science career opportunities
Find even more open roles in Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP), Computer Vision (CV), Data Engineering, Data Analytics, Big Data, and Data Science in general - ordered by popularity of job title or skills, toolset and products used - below.
- Open Business Intelligence Developer jobs
- Open Data Science Manager jobs
- Open Data Engineer II jobs
- Open Principal Data Scientist jobs
- Open Data Scientist II jobs
- Open Business Data Analyst jobs
- Open BI Analyst jobs
- Open Business Intelligence Engineer jobs
- Open Sr Data Engineer jobs
- Open Data Science Intern jobs
- Open Lead Data Analyst jobs
- Open Senior Business Intelligence Analyst jobs
- Open Sr. Data Scientist jobs
- Open Junior Data Scientist jobs
- Open MLOps Engineer jobs
- Open Software Engineer, Machine Learning jobs
- Open Azure Data Engineer jobs
- Open Manager, Data Engineering jobs
- Open Marketing Data Analyst jobs
- Open Data Analytics Engineer jobs
- Open Data Engineer III jobs
- Open Junior Data Engineer jobs
- Open Data Analyst II jobs
- Open Data Engineering Manager jobs
- Open Product Data Analyst jobs
- Open Data quality-related jobs
- Open Tableau-related jobs
- Open Excel-related jobs
- Open Privacy-related jobs
- Open ML models-related jobs
- Open Data pipelines-related jobs
- Open APIs-related jobs
- Open PhD-related jobs
- Open PyTorch-related jobs
- Open Finance-related jobs
- Open LLMs-related jobs
- Open TensorFlow-related jobs
- Open Data visualization-related jobs
- Open Consulting-related jobs
- Open Business Intelligence-related jobs
- Open Deep Learning-related jobs
- Open Generative AI-related jobs
- Open NLP-related jobs
- Open Data governance-related jobs
- Open CI/CD-related jobs
- Open DevOps-related jobs
- Open Kubernetes-related jobs
- Open Git-related jobs
- Open Hadoop-related jobs
- Open Docker-related jobs