Study Delivery Associate – Clinical Research
Location: Hyderabad, India
Work Mode: On-site
Employment Type: Full-Time
Category: Research / Clinical Operations
Job ID: R-232814
Posted On: 18 December 2025
Company: Amgen
About Amgen
Amgen is a global biotechnology leader committed to discovering, developing, manufacturing, and delivering innovative medicines for patients with serious diseases. With over four decades of scientific leadership, Amgen integrates advanced biology with cutting-edge technology and human genetic data to push the boundaries of medical innovation and improve lives worldwide.
Role Overview
Amgen is hiring a Study Delivery Associate to support global clinical trial execution and delivery activities at its Hyderabad site. This role provides essential administrative, operational, and coordination support to clinical trial teams, ensuring studies are executed efficiently, compliantly, and on schedule.
The position is well-suited for professionals seeking a career in clinical operations, clinical trial management, or global study delivery within a multinational biopharmaceutical organization.
Key Responsibilities
Study Planning and Coordination
Support the development, maintenance, and accuracy of study-level trackers, dashboards, timelines, and operational tools
Coordinate logistics for investigator meetings, study-related events, and site communications
Manage assigned study start-up activities, including system setup, user access, and document readiness
Study Execution and Oversight
Monitor study performance using dashboards and reports, including enrollment progress, data flow, and quality indicators
Support and lead assigned Risk-Based Quality Management (RBQM) activities, including risk assessments and mitigation planning
Track and report study progress, collaborating with Study Delivery Managers and vendors to resolve operational issues
Support global recruitment and retention activities to help meet enrollment targets
Stakeholder and Team Collaboration
Build strong working relationships with internal study teams, vendors, and investigator sites
Serve as a point of contact for routine study updates and communications
Identify, prioritize, and escalate risks to ensure timely and informed decision-making
Site, Vendor, and Systems Management
Coordinate with vendors and suppliers to ensure timely, high-quality, and compliant deliverables
Maintain accurate and timely data in clinical trial systems such as CTMS
Support data review, query resolution, and reconciliation activities
Manage Trial Master File (TMF) documentation to ensure inspection readiness
Process Improvement and Knowledge Sharing
Contribute to best practices, process optimization, and knowledge-sharing initiatives
Identify opportunities for process streamlining and automation
Support CAPA activities and implement lessons learned across studies
Experience and Qualifications
Minimum Qualifications
Bachelor’s degree in life sciences or a related field
OR
Associate degree with 4 years of clinical execution experience
OR
High school diploma / GED with 6 years of clinical execution experience
Preferred Experience
Minimum 2 years of work experience in life sciences or a medically related field
At least 1 year of experience in biopharmaceutical clinical research within a biotech, pharmaceutical, or CRO environment
Experience supporting global or multi-regional clinical trials
Required Skills and Competencies
Strong understanding of clinical trial processes, operations, and oversight
Hands-on experience with CTMS, eTMF, EDC, and clinical trial documentation workflows
Proficiency in Microsoft Word, Excel, PowerPoint, and related tools
Experience in tracking, filing, and maintaining essential clinical documents (protocols, ICFs, regulatory submissions)
Strong attention to detail with the ability to maintain inspection-ready documentation
Ability to collaborate effectively across culturally diverse global teams
Strong problem-solving skills with a proactive and curious mindset
Ability to manage multiple tasks and adapt to changing priorities
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
Amgen is committed to providing reasonable accommodations for individuals with disabilities throughout the recruitment and employment process.
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