Clinical Study Data Delivery Manager
Amgen Technology Private Limited
Work from Office
Full Time
Min. 5 yearsJob Description
Study Data Delivery Mgr
Career Category
ClinicalJob Description
In this vital role you are accountable for the management and oversight of data collected within a study/program, you will lead end-to-end data management and ensure high-quality, timely, and decision-ready data that enables successful clinical trial delivery.
- Serve as the single accountable leader for study-level data management, driving quality, delivery, and cross-functional alignment, locally and globally
- Lead development and execution of the Data Management Plan and Integrated Data Review Plan (IDRP) aligned to protocol and program strategy
- Drive database build, UAT, and go-live readiness in partnership with Database Design and Acquisition teams
- Oversee study conduct activities including data cleaning, query management, reconciliation, and database lock preparation, ensuring we are ‘delivery ready’ at all times
- Monitor study data metrics (e.g., eCRF entry, Non-CRF data collection, query aging, reconciliation backlog, KRIs) and proactively resolve issues to ensure on-time delivery
- Lead data deliverables, proactive in follow up, ensuring issue resolution and high-quality outputs
Basic Qualifications:
- Doctorate Degree OR
- Master’s Degree and 2 years of life science, computer sciences, business administration experience OR
- Bachelor’s degree and 4 years of life science, computer science, business administration experience OR
- Associate’s degree and 8 years of life science, computer science, business administration experience OR
- High school diploma / GED and 10 years of life science, computer science, business administration experience
Preferred Qualifications:
- 5 years’ work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
- Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
- Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
Experience Level
Mid LevelJob role
Job requirements
About company
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