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Amgen

Makes biotech medicines for serious illnesses

Data Delivery Lead

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeHyderabad, Telangana, IndiaIn-person

About the Job

Requirements

  • Preferred: 8–15 years of work experience in life sciences or a medically related field, including 5 years of biopharmaceutical clinical research experience obtained while working on clinical trials at a biotechnology, pharmaceutical, or contract research organization company.
  • Preferred: Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials.
  • Preferred: Experience managing and overseeing external vendors, such as contract research organizations, central laboratories, and imaging vendors.

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 aligned to the protocol and program strategy.
  • Drive database build, user acceptance testing, 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 delivery readiness at all times.
  • Monitor study data metrics, including electronic case report form entry, non-case-report-form data collection, query aging, reconciliation backlog, and key risk indicators, and proactively resolve issues to ensure on-time delivery.
  • Lead data deliverables and proactively follow up to ensure issue resolution and high-quality outputs.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size
10,001+
Company stage
IPO
Headquarters
Thousand Oaks, CA
Founded
1980

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