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Amgen, a global biotechnology leader, is hiring a Study Delivery Associate in Hyderabad, India. This role is ideal for candidates looking to build or advance a career in clinical research operations, clinical trial management, and regulatory compliance.
The position focuses on clinical trial coordination, CTMS management, documentation, and study delivery support, making it highly relevant for candidates with experience in CROs, pharma companies, or biotech clinical trials.
๐ Key Job Highlights
- Company: Amgen
- Role: Study Delivery Associate
- Location: Hyderabad, India
- Job Type: Full-time, On-site
- Category: Clinical Research / Trial Operations
- Experience: 1โ2+ years preferred
๐ Roles & Responsibilities
1. Study Coordination
- Support clinical trial setup, trackers, dashboards, and timelines
- Assist Study Delivery Managers in monitoring study progress and milestones
- Track risks and support risk mitigation strategies
- Ensure inspection readiness and compliance with regulatory requirements
- Coordinate investigator meetings, site communications, and logistics
- Support study start-up activities including ICF tracking and system readiness
- Manage biological sample shipment and investigational product logistics
2. Clinical Data & Systems Management
- Maintain accurate data in CTMS (Clinical Trial Management System)
- Handle system access requests and user management
- Ensure timely and error-free clinical data entry
3. Documentation & Regulatory Support
- Prepare and maintain:
- Protocols
- Informed Consent Forms (ICFs)
- Monitoring Plans
- Support Trial Master File (TMF) filing and compliance
- Ensure documents are version-controlled and audit-ready
4. Process Improvement
- Contribute to clinical trial process optimization
- Share knowledge across teams to improve efficiency and consistency
๐ Qualifications & Eligibility
Basic Qualifications
- Bachelorโs Degree in Life Sciences / Pharmacy / Related field
OR - Associate degree + 4 years clinical experience
OR - High school diploma + 6 years clinical experience
Preferred Qualifications
- 2+ years experience in:
- Clinical research
- Clinical trial operations
- Experience in global clinical trials (CRO/Pharma/Biotech)
๐ก Required Skills (High-Value Keywords)
- Clinical Trial Management (CTMS, eTMF, EDC)
- Regulatory Compliance (ICH-GCP, documentation)
- Clinical Data Management
- Investigator Site Coordination
- Protocol & ICF Handling
- Microsoft Office (Excel, PowerPoint, Word)
- Trial logistics & sample management
- Cross-functional collaboration (global teams)
๐ฐ Salary (Estimated)
- โน4.5 LPA โ โน8 LPA (Based on experience and industry standards for entry-mid level clinical roles in India)
๐ Why Join Amgen?
- Work with a global biotech leader
- Exposure to advanced clinical trial systems (CTMS, eTMF)
- Opportunity to work on global clinical trials
- Strong focus on innovation, compliance, and patient safety
- Career growth in clinical operations and trial management
๐ฉ How to Apply
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