Study Delivery Associate – Clinical Research
Location: Hyderabad, India
Work Type: On-site
Job ID: R-232851
Industry: Biopharmaceuticals | Clinical Research
Experience Level: Entry to Early-Mid Career
Posted On: December 18, 2025
About Amgen
Amgen is a global biotechnology leader committed to discovering, developing, manufacturing, and delivering innovative medicines that address serious diseases. With more than four decades of scientific leadership, Amgen continues to advance clinical research by combining biology, technology, and human genetic data to improve patient outcomes worldwide.
Job Overview
Amgen is seeking a Study Delivery Associate to support end-to-end clinical trial execution through strong administrative, operational, and systems coordination. This role plays a critical part in ensuring studies are delivered on time, within regulatory requirements, and in alignment with global clinical trial standards.
The Study Delivery Associate works closely with the Study Delivery Team to manage clinical trial documentation, systems, training compliance, and operational processes across global studies.
Key Responsibilities
Clinical Study Coordination
Support setup and maintenance of study trackers, dashboards, and timelines
Communicate study progress, milestones, and deliverables to Study Delivery Managers
Track study actions, risks, and mitigation activities
Assist in preparation and documentation of risk and quality reviews
Ensure study team training completion and inspection readiness
Support investigator meetings, trial-related events, and global site communications
Assist with study start-up activities, including system setup, vendor access, ICF tracking, and document readiness
Coordinate vendor interactions and site engagement activities
Manage shipment, reconciliation, and analysis of biological samples
Support investigational product logistics and reconciliation processes
Data & Systems Management
Maintain accurate and timely data in clinical trial systems such as CTMS and training platforms
Support system access requests and user access management
Documentation & TMF Support
Assist in preparation, review, and maintenance of study documentation
Support regulatory submissions, monitoring plans, and study guides
Ensure accurate and timely Trial Master File (TMF) filing
Process Improvement & Knowledge Sharing
Contribute to continuous process improvement initiatives
Share operational knowledge and best practices across study teams
Required Qualifications
Education & Experience (any one of the following):
Bachelor’s degree in Life Sciences or related field
Associate’s degree with 4 years of clinical execution experience
High school diploma / GED with 6 years of clinical execution experience
Preferred Experience
Minimum 2 years of work experience in life sciences or medically related fields
At least 1 year of biopharmaceutical clinical research experience
Experience working on global clinical trials in a biotech, pharmaceutical, or CRO environment
Core Competencies & Skills
Strong understanding of clinical trial operations and regulatory compliance
Working knowledge of CTMS, eTMF, EDC, and clinical documentation workflows
Proficiency in Microsoft Word, Excel, PowerPoint, and related tools
Experience managing essential trial documents (protocols, ICFs, regulatory files)
High attention to detail with accurate data entry and documentation practices
Ability to collaborate effectively with global, cross-functional teams
Strong organizational, communication, and problem-solving skills
Proactive mindset with willingness to learn and take ownership of new tasks
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Reasonable accommodations are available for individuals with disabilities throughout the hiring process.
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