Amgen

Biotech

DatabaseDesignLead

Madurai, India FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Biotech
Problems you'll solve

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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