Amgen
Biotech
DatabaseDesignLead
Neural analysis suggests this role is
optimal for Senior candidates.
“Database Design Lead at Amgen. Skills: Database design, Database structure, CRF/form design, Edit checks, System integrations. Translate clinical study protocols into high-quality, fit-for-purpose database design and structure. Enable site efficient, accurate data, and timely collection to support study delivery and analysis”
What You'll Achieve.
High-quality, fit-for-purpose database design and structure; Site efficient, accurate data, and timely collection; Support study delivery and analysis; Robust, user-friendly database designs; Alignment to study objectives; Capture both TA and Statistical needs; Streamlined, interactive design; Zero tolerance for delays; Minimize delays with builds/programming; Protect data quality; Reducing unnecessary site drive; Study database is fit for purpose; Aligned to library definitions; Meets team requirements; Rapid resolution; Minimal escalation
Industry & Context.
Troubleshoot and resolve database design and integration issues; Rapid resolution; Minimal escalation
What They're Looking For.
Must Have
Bachelor's degree and 8-15 years of clinical execution experience
Nice to Have
5 years’ work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials, Experience in management and oversight of external vendors (e. g. , CROs, central labs, imaging vendors, etc. )
What You'll Do.
Translate clinical study protocols into high-quality
fit-for-purpose database design and structure
Enable site efficient
and timely collection to support study delivery and analysis
Translate study protocol requirements into robust
user-friendly database designs across multiple platforms
Ensure alignment to study objectives capturing both TA and Statistical needs
Lead end-to-end database build
including CRF/form design
and system integrations
interactive design meetings
Drive EDC go-lives with zero tolerance for delays
Proactively minimizing delays with builds/programming through planning and cross-functional alignment
value-driven edit checks that protect data quality and reducing unnecessary site drive what matters in design and programming requirements
Support study teams and core Data Management roles to ensure the study database is fit for purpose
aligned to library definitions
and meets team requirements
Troubleshoot and resolve database design and integration issues
How You'll Work.
Team & Collaboration
Cross-functional alignment; Engaging and working across clinical trial teams in multiple geographies; Support study teams and core Data Management roles
Communication Scope
Interactive design meetings; Offline reviews
Process & Methodology
Planning
Full Job Description
## **Career Category** Clinical Development ## ## **Job Description** **Join Amgen’s Mission of Serving Patients** At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **Database Design Lead** **What you will do** Let’s do this. Let’s change the world. In this vital role you will translate clinical study protocols into high-quality, fit-for-purpose database design and structure that enables site efficient, accurate data, and timely collection to support study delivery and analysis. * Translate study protocol requirements into robust, user-friendly database designs across multiple platforms such as Vault CDMS, RAVE, ensuring alignment to study objectives capturing both TA and Statistical needs * Lead end-to-end database build, including CRF/form design, edit checks, rules, and system integrations, with a focus on streamlined, interactive design approaches; meetings will be a mixture of online virtual as well as offline reviews * Drive EDC go-lives with zero tolerance for delays, proactively minimizing delays with builds/programming through strong planning and cross-functional alignment * Design efficient, value-driven edit checks that prote
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