Study Delivery Sr Associate

Career Category

Clinical

Job Description

Job Description: 

Study Delivery Associate 

Role Name:   Study Delivery Sr Associate

Role GCF:  4

ABOUT AMGEN

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.

ABOUT THE ROLE

Role Description:

The Study Delivery Associate provides essential administrative and operational support to clinical trial management activities. This role supports the Study Delivery   T eam 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:

Study Coordination ​

Support the setup and maintenance of study-level trackers,   dashboards   and timelines.   ​

Communicate study progress,   timelines   and deliverables to the Study Delivery Manager. ​

Assist   with tracking and following up on study actions, including risk mitigation actions. ​

Assist   with the preparation and record keeping of risk & quality reviews. ​

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. ​

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 .

.