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
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