Study Delivery Sr Associate in Hyderabad, भारत

Senior Associate supporting clinical trial operations and coordination at Amgen in Hyderabad. Manages study timelines, regulatory compliance, data systems, and documentation while facilitating communication between study teams and stakeholders.

Responsibilities

• Maintain study trackers, dashboards, and timelines; communicate progress to Study Delivery Manager
• Track study actions and risk mitigation activities; prepare records for quality and risk reviews
• Manage clinical trial systems data entry, access requests, and system administration
• Prepare, review, and maintain regulatory submissions, protocols, ICF tracking, and trial master file documentation
• Coordinate investigational product logistics, biological sample reconciliation, and site engagement activities

Requirements

• Bachelor's degree or Associate's degree with 4 years clinical execution experience
• 2 years life sciences/medical field experience with 1 year biopharmaceutical clinical research
• Proficiency in CTMS, eTMF, EDC, and Microsoft Office applications
• Knowledge of clinical trial processes, regulatory requirements, and document management
• Strong data entry accuracy and attention to detail in managing trial information
• Ability to work collaboratively across global teams with cultural sensitivity