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Study Delivery Associate

India, Hyderabad · Job Posted April 05, 2026
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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. The Study Delivery Associate may also support specialized activities to promote expertise, quality, and consistency across studies. Key responsibilities include maintaining accurate and timely data within clinical systems (e.g., CTMS) and supporting study training and related operational requirements.

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
  • 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
  • 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 & share knowledge and experience

Requirements

  • Bachelor’s degree
  • Associate’s degree and 4 years of clinical execution experience
  • High school diploma / GED and 6 years of clinical execution experience
  • 2 years' work experience in life sciences or medically related field
  • 1 year 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
  • Experience with tracking and filing of essential documents
  • Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools
  • Ability to maintain accurate and timely data entry
  • Cultural sensitivity and collaboration across global teams
  • Ability to recognize, highlight and resolve issues
  • Demonstrates curiosity and willingness to take on new tasks

What we offer

Reasonable accommodation for individuals with disabilities

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  • 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
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amgen.com Logo
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Requirements
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  • Strong skills in using MS Word, Excel, PowerPoint, and other relevant software
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  • Assist with tracking and following up on study actions, including risk mitigation actions
  • Assist with the preparation and record keeping of risk & quality reviews
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  • Identifies discrepancies and escalates appropriately
  • 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
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  • Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools (e.g., vendor management, sample tracking, drug supply planning) to ensure accuracy and visibility
  • Coordinate logistics for investigator meetings, trial events, and site communications
  • Manage assigned start-up activities, including system setup, access management, and document readiness, ensuring completion to required standards
  • Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks
  • Lead delivery of assigned risk and quality management activities
  • Track and report study progress, coordinating with Study team and vendors to resolve operational issues and maintain compliance
  • Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved
  • Manage Study Training system activities and oversight
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  • 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
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Arrow Right

Study Delivery Sr Associate

The Study Delivery Associate provides essential administrative and operational s...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
Job Responsibility
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
  • Fulltime
Read More
Arrow Right

Study Delivery Senior Associate

The Study Delivery Senior Associate provides essential global study management s...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree
  • Bachelor’s degree and 2 years of clinical execution experience
  • Associate’s degree and 6 years of clinical execution experience
  • High school diploma / GED and 8 years of clinical execution experience
  • 3 years’ work experience in life sciences or medically related field, including 1 year of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
  • Experience working on global clinical trials
  • Strong collaborative and effective communication skills within a team environment
  • Understands importance of accuracy in documentation, data tracking, and compliance checks
  • 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
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  • Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools (e.g., vendor management, sample tracking, drug supply planning) to ensure accuracy and visibility
  • Coordinate logistics for investigator meetings, trial events, and site communications
  • Manage assigned start-up activities, including system setup, access management, and document readiness, ensuring completion to required standards
  • Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks
  • Lead delivery of assigned risk and quality management activities
  • Track and report study progress, coordinating with Study team and vendors to resolve operational issues and maintain compliance
  • Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved
  • Manage Study Training system activities and oversight
  • Build and maintain effective relationships with internal study team members, vendors and investigator sites
  • Act as a point of contact for routine study updates, ensuring stakeholders are informed and aligned
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  • Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
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