Ensure completion of study team training and inspection readiness activities to maintain compliance with regulatory requirements.
Assist with trial-related events, global site communications, and logistics for investigator meetings
Support study start-up activities, including system setup, supplier access management, ICF tracking and document readiness.
Support vendor relationships and site engagement strategies.
Manage shipment, reconciliation and analysis of biological samples.
Coordinate investigational product logistics, ensuring compliance with reconciliation processes.
Data & Systems Management
Maintain clinical trial systems (e.g., CTMS, study training), ensuring timely and accurate data entry.
Support system access requests and access management.
Document Preparation
Assist with preparing, reviewing and maintaining study documentation, including regulatory submissions, monitoring plans and study guides.
Support TMF filing.
Process Improvement & Knowledge Sharing
Contribute to process improvement and share knowledge & share knowledge and experience.
Basic Qualifications and Experience
Bachelor’s degree OR
Associate’s degree and 4 years of clinical execution experience OR
High school diploma / GED and 6 years of clinical execution 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
Competencies
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
Experience with tracking and filing of 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
Cultural sensitivity and collaboration across global teams.
Ability to recognize, highlight and resolve issues. Demonstrates curiosity and willingness to take on new tasks.
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.
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