Posted: 2 weeks ago
Posted: 2 weeks ago
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Job Description
Role Name: Study Delivery Associate
Role GCF: 3
ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the worlds toughest diseases, and make peoples 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 whats 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, 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:
- Bachelors degree OR
- Associates 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 companyExperience 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.
Skills
LogisticsMicrosoftDataEtmfResearchManagementMaintenanceClinicalOperationsLogisticsMaintenanceDeliveryIf a job posting appears fraudulent, asks for payment, contains misleading information, or violates our guidelines, please report it immediately. Our team will review it promptly, Jobaaj does not charge any fee from the applicants.
About Company
Amn Technologies Ltd is a computer software company based out of 145-157 St John Street, London, United Kingdom. Industries: Software Development. It's a private unlisted company and is classified as'company limited by shares'. Company's authorized capital stands at Rs 60.0 lakhs. AMN TECHNOLOGY PRIVATE LIMITED is a private limited Indian company based in Bangalore, India and it was officially incorporated on 29/12/2014.
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