Amgen CDM Systems Mgr (EDC Technical Specialist) in Uxbridge, United Kingdom
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.
CDM Systems Manager (EDC Technical Specialist)
What you will do
In this vital role you as the Electronic Data Capture (EDC) integration expert for Amgen’s clinical trials, will partner with the EDC vendor and cross functional study teams to provide premium study level support for the Rave EDC platform within the Global Development Operations (GDO).
You will provide study-level support for established system integration capabilities with EDC during study start-up, conduct and closeout (e.g. study-level Rave Safety Gateway (RSG) mapping between Rave EDC and Oracle Argus systems)
You will partner with clinical study team and EDC provider to gather business and technical requirements and develop customized study-level solutions as needed
You will maintain overall health of EDC platform by balancing study-level system activities
You will support ad-hoc Rave EDC data generation requests via complex SQL programming; i.e. familiar with Rave EDC backend database schema
You will partner with the EDC Platform Team to deliver an up-to-date, scalable and high-performance EDC platform; include EDC platform upgrades etc
You will lead or support new EDC capabilities or clinical system integrations
You will lead or support new robust Rave EDC data sharing mechanisms (API, webservices, flat files) within internal technical ecosystem
You will lead or deliver innovative and emerging technical solutions within the clinical trial landscape (i.e. Webservices, eSource, mHealth etc)
You will build effective relationships and partnerships within Global Development Operations (GDO), IS, Global Statistical Programming, Global Safety, Compliance, Quality Assurance, and other key stakeholders and Functional Service Provider (FSP)
Be part of our team
You would be joining the EDC Operations Team, responsible for enabling clinical trial operations with innovative and emergent technologies including clinical trial platform and study portfolio support as well as supporting capabilities that advances next generation of trial execution.
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:
A proven track record and experience in working in a clinical study team matrix with strong project management and technical oversight in addition to attention to detail while ensuring deliverables remain committed to goal(s) and project timeline.
Extensive knowledge of Data Management in the Pharmaceutical or Biotech arena
Technical Medidata Rave experience or similar EDC platform - Rave EDC, Rave Safety Gateway (RSG), Medidata Coder, iMedidata platform (Preferred but not essential)
Must have sound problem resolution, judgment, and decision-making abilities
A strong agility to learn new things, adapt to changes that surround the EDC ecosystem, be able to articulate a clear action or design, and collaborate (strong team player management style) with cross-functional stakeholders.
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
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.
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.