Study Delivery Senior Associate

About the role

Study Delivery Senior Associate at Amgen provides global operational support to clinical study teams, ensuring timely, high-quality, compliant study execution. Responsibilities include developing and maintaining study trackers, coordinating logistics, managing start‑up activities, monitoring enrollment and data quality, leading risk and quality management, engaging stakeholders, and supporting vendor and system operations. The role requires strong documentation, data management, and regulatory compliance skills, experience with CTMS, eTMF, EDC, and MS Office, and a background in clinical trial execution. The position is based in Hyderabad, India, and is a full‑time role.

What you’ll do

• Support and sometimes own 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.
• 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.
• Identify, prioritize, and elevate risks effectively to support swift, informed decisions.
• Coordinate with vendors and suppliers to ensure quality, speed, and consistency in deliverables.
• Maintain and monitor clinical trial systems (e.g., CTMS), ensuring accurate and timely data entry and reporting.
• Support data collection oversight, including query resolution and reconciliation activities.
• Manage trial documentation (e.g., TMF) to ensure inspection readiness.
• Contribute to best practice development, knowledge-sharing and process improvement within the study support community.
• Proactively identify and highlight opportunities to streamline / automate activities within remit.
• Support Corrective and Preventive Actions (CAPA) processes and embed lessons learned across studies.

What you’ll bring

• Master’s degree OR
• Bachelor’s degree and 2 years of clinical execution experience OR
• Associate’s degree and 6 years of clinical execution experience OR
• High school diploma / GED and 8 years of clinical execution experience

Nice to have

• 3 years work experience in life sciences or medically related field, including 1 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience working on global clinical trials

Skills

Education

Bachelor’s degree