Title: Study Delivery Associate – Hyderabad, India
Location: Hyderabad, India
Job Type: Full-Time
Category: Clinical Research / Study Operations
Company Overview:
Amgen is a global biotechnology leader that harnesses biology and technology to tackle the world’s toughest diseases. With more than 40 years of innovation, Amgen discovers, develops, manufactures, and delivers medicines that improve the lives of millions of patients.
Role Overview:
We are seeking a Study Delivery Associate to provide administrative and operational support to clinical trial management activities. This role supports the Study Delivery Team in ensuring study timelines are met, regulatory compliance is maintained, and standardized processes for clinical trial coordination, documentation, and systems management are executed efficiently.
Key Responsibilities:
Study Coordination:
Support setup and maintenance of study-level trackers, dashboards, and timelines.
Communicate study progress, deliverables, and timelines to the Study Delivery Manager.
Assist with risk mitigation tracking, quality reviews, and inspection readiness activities.
Support study start-up, system setup, vendor access management, ICF tracking, and document readiness.
Assist with trial-related events, global site communications, and investigator meeting logistics.
Manage shipment, reconciliation, and analysis of biological samples.
Coordinate investigational product logistics, ensuring compliance with reconciliation processes.
Data & Systems Management:
Maintain clinical trial systems (CTMS, eTMF, EDC) with accurate and timely data entry.
Support system access requests and access management.
Document Preparation:
Assist in preparing, reviewing, and maintaining study documentation, including regulatory submissions, monitoring plans, and study guides.
Support Trial Master File (TMF) filing and version control.
Process Improvement & Knowledge Sharing:
Contribute to process improvement initiatives and share knowledge and experience within the team.
Qualifications & Experience:
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: 2 years’ experience in life sciences or medically related fields, including 1 year in biopharmaceutical clinical research (CRO, pharma, or biotech).
Skills & Competencies:
Expertise in clinical trial processes, operations, and oversight.
Proficiency in Microsoft Office (Word, Excel, PowerPoint) and relevant clinical trial software.
Working knowledge of CTMS, eTMF, and EDC systems.
Strong document management skills ensuring inspection-ready, version-controlled documentation.
Ability to maintain accurate trial data, protocol adherence, and regulatory compliance.
Cultural sensitivity and collaborative skills to work effectively with global teams.
Strong problem-solving skills, curiosity, and willingness to take on new responsibilities.
Why Join Amgen:
Be part of a leading biotech company shaping the future of medicine.
Work on global clinical trials with cross-functional teams.
Gain exposure to clinical trial operations, documentation, and regulatory compliance.
Contribute to life-changing therapies that impact millions of patients worldwide.
Apply Now: Join Amgen to support clinical trial delivery and help bring innovative medicines to patients globally.
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Siliguri |Illinois :
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