Job Summary
Amgen, a global leader in biotechnology, is seeking a detail-oriented and motivated professional to join our team in Hyderabad, India, as a Study Delivery Associate. This is a full-time, on-site position ideal for candidates looking to build or advance their career in clinical research operations, trial management, and regulatory compliance. In this role, you will provide critical support to our clinical delivery teams, ensuring the seamless execution of global clinical trials through effective documentation, system management, and cross-functional coordination.
Responsibilities
As a Study Delivery Associate, you will play a pivotal role in the operational success of our clinical studies. Your key responsibilities will include:
Clinical Trial Coordination
- Support the setup of clinical trials by managing trackers, dashboards, and project timelines.
- Assist Study Delivery Managers in monitoring study progress, identifying potential risks, and supporting mitigation strategies.
- Coordinate site communications, investigator meetings, and essential trial logistics.
- Manage operational aspects of study start-up, including Informed Consent Form (ICF) tracking and system readiness.
- Oversee the logistics of biological sample shipments and investigational products.
Clinical Data & Systems Management
- Maintain accurate and up-to-date data within the Clinical Trial Management System (CTMS).
- Handle system access requests and perform routine user management.
- Ensure high-quality, timely, and error-free entry of clinical data.
Documentation & Regulatory Compliance
- Prepare, maintain, and ensure version control for critical study documents, including protocols, ICFs, and monitoring plans.
- Support Trial Master File (TMF) management to ensure the study is audit-ready and compliant with ICH-GCP guidelines.
- Assist in maintaining inspection readiness at all times.
Process Improvement
- Contribute to the optimization of clinical trial processes.
- Share best practices and knowledge across global teams to enhance overall operational efficiency and consistency.
Requirements
We are looking for candidates who possess a strong foundation in clinical research and a commitment to operational excellence.
Basic Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field; OR
- Associate degree with at least 4 years of relevant clinical experience; OR
- High school diploma with at least 6 years of relevant clinical experience.
Preferred Qualifications:
- 2+ years of experience in clinical research or clinical trial operations.
- Proven experience working within a CRO, pharmaceutical, or biotechnology environment on global clinical trials.
- Proficiency in clinical systems (CTMS, eTMF, EDC).
- Strong understanding of regulatory requirements, specifically ICH-GCP.
- Excellent proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).
- Strong interpersonal skills with the ability to collaborate effectively across diverse, cross-functional global teams.
Benefits
Joining Amgen means becoming part of an organization dedicated to innovation, patient safety, and scientific excellence. Benefits of this role include:
- Global Impact: Opportunity to work with a world-renowned biotech leader on high-priority global clinical trials.
- Professional Development: Exposure to advanced clinical trial management systems and industry-leading workflows.
- Career Growth: A clear pathway for advancement within clinical operations and trial management.
- Collaborative Culture: Engagement with a diverse team focused on high-quality delivery and innovation.
- Competitive Compensation: An attractive salary package (estimated between ₹4.5 LPA – ₹8 LPA) commensurate with experience and industry standards.
How to Apply
If you are a driven professional looking to contribute to groundbreaking clinical research, we encourage you to apply. Please visit our official career portal to submit your application and view the full job details.
Click Here to Apply on the Official Amgen Careers Page