Study Delivery Associate – Clinical Research
Location: Hyderabad, India
Work Type: On-site
Job Type: Full-Time
Job ID: R-232851
Industry: Clinical Research | Biotechnology | Pharmaceuticals
Experience Required: 1–4 Years (clinical research / trial operations)
About Amgen
Amgen is a global biotechnology leader focused on discovering, developing, manufacturing, and delivering innovative medicines that address some of the world’s most complex diseases. With more than four decades of scientific leadership, Amgen combines advanced biology, data science, and cutting-edge technology to improve patient lives worldwide.
Role Overview
The Study Delivery Associate plays a critical operational and administrative role in supporting global clinical trial execution. This position works closely with the Study Delivery Team to ensure studies are delivered on time, in compliance with regulatory requirements, and aligned with standardized clinical trial processes. The role involves coordination, system and document management, vendor and site support, and maintenance of accurate clinical trial data.
This opportunity is ideal for professionals seeking hands-on experience in global clinical research operations within a leading biopharmaceutical organization.
Key Responsibilities
Study Coordination & Trial Support
Support setup and maintenance of study-level trackers, dashboards, timelines, and deliverables
Communicate study progress, milestones, and risks to the Study Delivery Manager
Track study actions, risks, and mitigation plans and support quality review documentation
Assist in ensuring study team training completion and inspection readiness
Support global investigator meetings, site communications, and trial-related logistics
Contribute to study start-up activities including system access, document readiness, supplier onboarding, and ICF tracking
Support vendor coordination and site engagement activities
Manage shipment, reconciliation, and analysis of biological samples
Coordinate investigational product logistics in compliance with reconciliation and regulatory standards
Data & Clinical Systems Management
Maintain accurate and timely data in clinical trial systems such as CTMS and study training platforms
Support system access requests and access management activities
Documentation & Trial Master File (TMF)
Assist in the preparation, review, and maintenance of clinical trial documentation including monitoring plans, regulatory submissions, and study guides
Support TMF filing to ensure inspection-ready documentation
Process Improvement & Knowledge Sharing
Contribute to continuous process improvement initiatives
Share operational knowledge and best practices across study teams
Required Qualifications & Experience
Education (any one of the following):
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field
Associate degree with 4 years of clinical trial execution experience
High school diploma/GED with 6 years of clinical trial execution experience
Experience:
Minimum 1–2 years of experience in life sciences or medically related roles
At least 1 year of biopharmaceutical clinical research experience within a pharmaceutical, biotechnology, or CRO environment preferred
Experience supporting global clinical trials is an advantage
Required Skills & Competencies
Strong understanding of clinical trial operations and regulatory compliance
Working knowledge of CTMS, eTMF, EDC, and clinical trial documentation workflows
Proficiency in Microsoft Word, Excel, PowerPoint, and related documentation tools
Ability to maintain accurate, timely, and compliant clinical trial data
Experience managing investigator documentation, protocol adherence, and regulatory records
Strong organizational skills with attention to detail and inspection readiness
Ability to collaborate effectively across culturally diverse, global teams
Proactive mindset with problem-solving capabilities and willingness to learn new processes
SEO & GEO Optimized Keywords
Study Delivery Associate Jobs India, Clinical Research Jobs Hyderabad, Amgen Clinical Trials Careers, Clinical Operations Associate India, CTMS eTMF Jobs India, Biopharmaceutical Research Jobs Hyderabad.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer and is committed to creating an inclusive and diverse workplace. All employment decisions are based on business requirements, merit, and qualifications without discrimination of any kind. Reasonable accommodations are provided for individuals with disabilities throughout the hiring process.
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