Role Name:Study Delivery Sr Associate
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier,fullerand longer. We discover, develop,manufactureand deliver innovative medicines to help millions of patients. Amgen helpedestablishthe biotechnology industry more than 40 years ago andremainson thecutting-edgeof innovation, using technology and human genetic data to push beyondwhat’sknown today.
The Study Delivery Associate provides essential administrative and operational support to clinical trial management activities. This role supports the Study DeliveryTeam in meeting study timelines, ensuring regulatory compliance, and executing standardized processes related to clinical trial coordination,documentand system management.
TheStudy DeliveryAssociatemayalsosupportspecializedactivities to promoteexpertise, quality, and consistency across studies. Key responsibilities includemaintainingaccurateandtimelydata within clinical systems (e.g., CTMS) and supporting study training and related operational requirements.
Roles & Responsibilities:
Support study start-up activities, including system setup, supplier access management, ICF tracking and document readiness.
Data & Systems Management
Assistwith preparing,reviewingandmaintainingstudy documentation, including regulatory submissions, monitoringplansand study guides.
Process Improvement & Knowledge Sharing
Basic Qualifications and Experience:
PreferredQualifications 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
Expertisein 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
Experience withtracking and filingof essential documents such as protocols, informed consent forms, and regulatory submissions to ensure documents are version-controlled and inspection-ready.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 toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to requestan accommodation.
