Study Delivery Sr Associate — Structured Job Format
Job Details
Job Title: Study Delivery Sr Associate
Company: Amgen
Job ID: R-238190
Category: Clinical
Location: Hyderabad, India
Work Mode: On-site
Date Posted: May 6, 2026
Role GCF Level: 4
Company Overview
Amgen is a global biotechnology company focused on discovering, developing, manufacturing, and delivering innovative medicines. The company combines biology and technology to address complex diseases and improve patient outcomes worldwide.
Job Overview
The Study Delivery Sr Associate provides administrative and operational support for clinical trial management activities.
The role focuses on:
Supporting study delivery teams
Managing clinical trial systems and documentation
Ensuring regulatory compliance
Coordinating study operations and logistics
Maintaining accurate clinical trial data
The position also supports:
Study training
Vendor coordination
Inspection readiness
Process improvement initiatives
Key Responsibilities
Study Coordination
Support setup and maintenance of:
Study trackers
Dashboards
Timelines
Communicate study progress and deliverables to Study Delivery Managers
Track study actions and risk mitigation activities
Assist with:
Risk and quality reviews
Trial-related events
Investigator meeting logistics
Global site communications
Support study start-up activities including:
System setup
Supplier access management
ICF tracking
Document readiness
Support vendor relationships and site engagement strategies
Coordinate:
Biological sample shipment and reconciliation
Investigational product logistics
Data & Systems Management
Maintain clinical trial systems including:
CTMS
Study training systems
Ensure accurate and timely data entry
Support system access requests and user access management
Documentation & Regulatory Support
Prepare, review, and maintain:
Regulatory submissions
Monitoring plans
Study guides
Study documentation
Support TMF (Trial Master File) filing activities
Ensure inspection readiness and document version control
Process Improvement & Knowledge Sharing
Participate in process improvement initiatives
Share operational knowledge and best practices across teams
Required Qualifications
Education
One of the following:
Bachelor’s degree
OR
Associate’s degree with 4 years of clinical execution experience
OR
High School Diploma/GED with 6 years of clinical execution experience
Preferred Qualifications
Experience
2 years of experience in:
Life sciences
Medically related field
Including:
1 year of biopharmaceutical clinical research experience
Experience in:
Pharmaceutical companies
Biotechnology companies
CRO environments
Experience working on global clinical trials
Required Skills & Competencies
Clinical Trial Operations
Knowledge of:
Clinical trial processes
Clinical operations
Trial oversight
Regulatory compliance
Systems & Technical Skills
Working knowledge of:
CTMS
eTMF
EDC systems
Proficiency in:
MS Word
Excel
PowerPoint
Documentation Management
Experience managing:
Protocols
Informed consent forms (ICFs)
Regulatory documents
Ability to maintain inspection-ready documentation
Professional Skills
Strong organizational and coordination abilities
Ability to identify and resolve operational issues
Strong attention to detail
Curiosity and willingness to learn new tasks
Ability to collaborate across global and multicultural teams
Work Environment
On-site role in Hyderabad, India
Global cross-functional collaboration
Clinical research and trial operations environment
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