Study Delivery Associate

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the worlds toughest diseases, and make peoples 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 beyondwhatsknown 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 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:

Study Coordination

• Support the setup and maintenance of study-level trackers,dashboardsand timelines.

• Communicate study progress,timelinesand deliverables to the Study Delivery Manager.

• Assistwith tracking and following up on study actions, including risk mitigation actions.Assistwith the preparation and record keeping of risk quality reviews.

• Ensure completion of study team training andinspectionreadiness activities tomaintaincompliance with regulatory requirements.

• Assistwith trial-related events, global site communications, andlogisticsfor 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,reconciliationand analysis of biological samples.

• Coordinate investigational productlogistics, ensuring compliance with reconciliation processes.

Data Systems Management

• Maintain clinical trial systems (e.g., CTMS, study training), ensuringtimelyandaccuratedata entry.

• Support system access requests and access management.

Document Preparation

• Assistwith preparing,reviewingandmaintainingstudy documentation, including regulatory submissions, monitoringplansand study guides.

• Support TMF filing.

Process Improvement Knowledge Sharing

• Contribute to process improvement and share knowledgeshareknowledge and experience.

Basic Qualifications and Experience:

• Bachelors degree OR

• Associates degree and 4 years of clinical execution experience OR

• High school diploma / GED and 6 years of clinical execution 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 companyExperience working on global clinical trials

Competencies:

• 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 tomaintainaccurateandtimelydata 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,highlightand 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 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.