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Study Delivery Sr Associate

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Amgen

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Location:
India , Hyderabad

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Category:
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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

The Study Delivery Associate provides essential administrative and operational support to clinical trial management activities. This role supports the Study Delivery Team in meeting study timelines, ensuring regulatory compliance, and executing standardized processes related to clinical trial coordination, document and system management.

Job Responsibility:

  • Support the setup and maintenance of study-level trackers, dashboards and timelines
  • Communicate study progress, timelines and deliverables to the Study Delivery Manager
  • Assist with tracking and following up on study actions, including risk mitigation actions
  • Assist with the preparation and record keeping of risk & quality reviews
  • Ensure completion of study team training and inspection readiness activities to maintain compliance with regulatory requirements
  • Assist with trial-related events, global site communications, and logistics for investigator meetings
  • Support study start-up activities, including system setup, supplier access management, ICF tracking and document readiness
  • Support vendor relationships and site engagement strategies
  • Manage shipment, reconciliation and analysis of biological samples
  • Coordinate investigational product logistics, ensuring compliance with reconciliation processes
  • Maintain clinical trial systems (e.g., CTMS, study training), ensuring timely and accurate data entry
  • Support system access requests and access management
  • Assist with preparing, reviewing and maintaining study documentation, including regulatory submissions, monitoring plans and study guides
  • Support TMF filing
  • Contribute to process improvement and share knowledge and experience

Requirements:

Bachelor's degree OR Associate's degree and 4 years of clinical execution experience OR High school diploma / GED and 6 years of clinical execution experience

Nice to have:

  • 2 years' work experience in life sciences or medically related field, including 1 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
  • Experience working on global clinical trials
  • Expertise in clinical trial processes, operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environments
  • Strong skills in using MS Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support
  • Experience with tracking and filing of essential documents such as protocols, informed consent forms, and regulatory submissions to ensure documents are version-controlled and inspection-ready
  • Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools
  • Ability to maintain accurate and timely data entry
  • Skilled in managing clinical trial data flow, investigator documentation, and protocol adherence while ensuring regulatory compliance
  • Cultural sensitivity and collaboration across global teams
  • Ability to recognize, highlight and resolve issues
  • Demonstrates curiosity and willingness to take on new tasks

Additional Information:

Job Posted:
May 15, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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