Study Data Deliver Mgr

Amgen Technology; Hyderabad; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Amgen Technology is seeking an experienced data management leader to oversee end-to-end data management for clinical study programs. You will drive data quality, timely delivery, and decision-ready datasets to support successful clinical trial delivery.

The role requires leading the Data Management Plan and IDRP, driving database build and go-live readiness, and coordinating with cross-functional teams globally to ensure delivery readiness at all times.

Qualifications

• Doctorate Degree OR
• Masters Degree and 2 years of life science, computer sciences, business administration experience OR
• Bachelors degree and 4 years of life science, computer science, business administration experience OR
• Associates 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

Responsibilities

• 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

Job description

Job Summary

Lets do this. Lets change the world. 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.

Responsibilities

• 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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an individual with the following qualifications.

Basic Qualifications

• Doctorate Degree OR
• Masters Degree and 2 years of life science, computer sciences, business administration experience OR
• Bachelors degree and 4 years of life science, computer science, business administration experience OR
• Associates 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.)