Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
The Study Delivery Associate provides essential administrative and operational support to clinical trial management activities. This role supports the Study Delivery Team in meeting study timelines, ensuring regulatory compliance, and executing standardized processes related to clinical trial coordination, document and system management.
The Study Delivery Associate may also support specialized activities to promote expertise, quality, and consistency across studies. Key responsibilities include maintaining accurate and timely data within clinical systems (e.g., CTMS) and supporting study training and related operational requirements.
Roles & Responsibilities:
- Assist with tracking and following up on study actions, including risk mitigation actions.Assist with the preparation and record keeping of risk & quality reviews.
Support study start-up activities, including system setup, supplier access management, ICF tracking and document readiness.
Data & Systems Management
Maintain clinical trial systems (e.g., CTMS, study training), ensuring timely and accurate data entry.
Assist with preparing, reviewing and maintaining study documentation, including regulatory submissions, monitoring plans and study guides.
Process Improvement & Knowledge Sharing
Basic Qualifications and Experience:
Preferred Qualifications and Experience:
2 years' work experience in life sciences or medically related field, including 1 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company Experience working on global clinical trials
Expertise in clinical trial processes, operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environments
Strong skills in using MS Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support
Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools. Ability to maintain accurate and timely data entry. Skilled in managing clinical trial data flow, investigator documentation, and protocol adherence while ensuring regulatory compliance
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 with 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.
