Data Delivery Lead

Amgen • High School Diploma • 3 months ago
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Salary
≈ $18k – $61k per year (Estimated)
Location
In office (Hyderabad)
Seniority
Staff · 5+ years exp
Employment
Full-Time
Overview
Company
Impact
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Amgen

Amgen is an American biotechnology company founded in Thousand Oaks in 1980 that became one of the first firms to turn recombinant protein research into large commercial medicines. Its history rests on Epogen and Neupogen, and its current portfolio spans bone health with Prolia and Evenity, inflammation with Otezla and Tezspire, cardiovascular disease with Repatha, oncology including the bispecific antibody Blincyto, and a biosimilars business built on its own manufacturing capacity. The company is listed on Nasdaq, is a component of the Dow Jones Industrial Average, and expanded further into rare disease through its acquisition of Horizon Therapeutics.
amgen.com • HQ: Thousand Oaks, United States • Biopharma • Drug Discovery • Biotechnology • Health Care • Pharmaceuticals • 1001-5000 employees • Est. 1980

Career Category

Clinical Development

Job 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.)
.
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