Study Delivery Sr Associate

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. ​

S upport vendor relationships and site engagement strategies. ​

M anage 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 .