Amgen
biotechnology
StudyDeliverySrAssociate
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Study Delivery Sr Associate at Amgen. Skills: Study Delivery, Clinical Trial Management, Data Management, Document Management, Process Improvement. Provides essential administrative and operational support to clinical trial management activities.. Supports the Study Delivery Team in meeting study timelines, ensuring regulatory compliance, and executing standardized processes related to clinical trial coordination, document and system management.”
Industry & Context.
Ability to recognize, highlight and resolve issues.
What They're Looking For.
Must Have
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
Nice to Have
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
What You'll Do.
Provides essential administrative and operational support to clinical trial management activities., Supports the Study Delivery Team in meeting study timelines, ensuring regulatory compliance, and executing standardized processes related to clinical trial coordination, document and system management., Supports specialized activities to promote expertise, quality, and consistency across studies., Maintains accurate and timely data within clinical systems (e.
, CTMS) and supporting study training and related operational requirements., 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., Support vendor relationships and site engagement strategies., Manage shipment, reconciliation and analysis of biological samples., Coordinate investigational product logistics, ensuring compliance with reconciliation processes., Maintain clinical trial systems (e.
, CTMS, study training), ensuring timely and accurate data entry., Support system access requests and access management., Assist with preparing, reviewing and maintaining study documentation, including regulatory submissions, monitoring plans and study guides., Support TMF filing., Contribute to process improvement and share knowledge & share knowledge and experience.
How You'll Work.
Team & Collaboration
Cross-functional coordination; vendor/stakeholder management; collaboration across global teams
Communication Scope
Communicate study progress, timelines and deliverables to the Study Delivery Manager.; global site communications
Process & Methodology
process management, resource planning
Full Job Description
## **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 Team 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, sup
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