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Study Delivery Senior Associate
About the role
Study Delivery Senior Associate at Amgen supports global clinical study teams, ensuring timely, high-quality, compliant execution. Responsibilities include developing study trackers, coordinating logistics, managing start‑up activities, monitoring enrollment and data quality, leading risk and quality management, reporting progress, and supporting recruitment strategies. The role also involves training system oversight, vendor engagement, data and systems management (CTMS, eTMF, EDC), audit and CAPA support, and process improvement. Candidates should have a Master’s degree or equivalent experience, strong collaboration and communication skills, expertise in clinical trial operations, proficiency with MS Office and clinical trial systems, and experience with global trials and vendor oversight. Preferred experience includes 3+ years in life sciences and 1 year in biopharma clinical research. The position is full‑time, based in Hyderabad, India, with on‑site work model.
What you’ll do
- Develop and maintain study-level trackers, dashboards, timelines, and tools (e.g., vendor management, sample tracking, drug supply planning)
- Coordinate logistics for investigator meetings, trial events, and site communications
- Manage start‑up activities, including system setup, access management, and document readiness
- Monitor global enrollment, data flow, and quality indicators using dashboards and reports
- Lead risk and quality management activities, track and report study progress, and resolve operational issues
- Engage vendors and suppliers, maintain clinical trial systems (CTMS), support data collection, and manage trial documentation (TMF)
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 in life sciences, including 1 year in biopharma clinical research on global trials.
- Experience with global clinical trials