Study Delivery Sr Associate in Hyderabad, भारत

Senior Associate providing study management support to clinical research teams at Amgen in Hyderabad. Responsible for coordinating study planning, monitoring execution, managing vendors and systems, and ensuring regulatory compliance throughout the trial lifecycle.

Responsibilities

• Develop and maintain study trackers, dashboards, timelines, and tools for vendor and supply management
• Monitor global enrollment, data flow, and quality indicators; proactively address deviations and risks
• Coordinate investigator meetings, trial events, site communications, and start-up activities
• Manage clinical trial documentation and systems; ensure accurate data entry and inspection readiness
• Support recruitment strategies, training oversight, vendor setup, and escalate issues to stakeholders

Requirements

• Master's degree OR Bachelor's with 2+ years clinical execution experience OR Associate's with 6+ years OR High school diploma with 8+ years
• 3 years life sciences work experience including 1 year biopharmaceutical clinical research at biotech, pharma, or CRO
• Experience with global clinical trials and clinical trial management systems (CTMS, eTMF, EDC)
• Strong proficiency in MS Office (Word, Excel, PowerPoint) and data management tools
• Knowledge of risk-based monitoring, audit processes, CAPA implementation, and regulatory compliance
• Vendor oversight and supplier management experience
• Demonstrated collaborative communication, attention to accuracy, and problem-solving abilities