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Study Delivery Senior Associate

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Amgen

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Location:
India , Hyderabad

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Category:
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Contract Type:
Not provided

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Salary:

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Job Description:

The Study Delivery Senior Associate provides essential global study management support to clinical study teams, ensuring timely, high-quality, and compliant study execution. They partner with Study Managers to deliver start-up and conduct activities, own specific study tasks and support risk monitoring and issue management.

Job Responsibility:

  • Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools
  • Coordinate logistics for investigator meetings, trial events, and site communications
  • Manage assigned start-up activities, including system setup, access management, and document readiness
  • Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators
  • Lead delivery of assigned risk and quality management activities
  • Track and report study progress, coordinating with Study team and vendors to resolve operational issues
  • Deliver assigned components of global recruitment and retention strategies
  • 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
  • Identify, prioritize, and escalate risks effectively
  • Lead vendors and supplier set-up
  • Maintain and monitor clinical trial systems
  • Support data collection oversight, including query resolution and reconciliation activities
  • Manage trial documentation to ensure inspection readiness
  • Contribute to best practice development, knowledge-sharing and process improvement
  • Proactively identify and highlight opportunities to streamline / automate activities
  • Support Audit/Inspections including Corrective and Preventive Actions (CAPA) processes

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
  • Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools
  • Experience with overseeing vendors and suppliers
  • Experience executing risk-based site monitoring, Audit and Inspections Corrective and Preventive Actions (CAPA) implementation, and risk mitigation
  • Cultural sensitivity and collaboration across global teams
  • Ability to recognize, highlight and resolve issues
  • Understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles
  • Experience with tracking and filing of essential documents such as protocols, informed consent forms, and regulatory submissions

Additional Information:

Job Posted:
January 04, 2026

Work Type:
On-site work
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