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Amgen

Makes biotech medicines for serious illnesses

Study Delivery Senior Associate

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeHyderabad, Telangana, IndiaNo salary listedIn-person

About the Job

Requirements

  • A master's degree, or a bachelor's degree and 2 years of clinical execution experience, or an associate's degree and 6 years of clinical execution experience, or a high school diploma/GED and 8 years of clinical execution experience.
  • Three years of work experience in a life sciences or medically related field, including one year of biopharmaceutical clinical research experience working on clinical trials in a biotechnology, pharmaceutical, or contract research organization company is preferred.
  • Experience working on global clinical trials is preferred.
  • Strong collaborative and effective communication skills within a team environment.
  • Ability to maintain accuracy in documentation, data tracking, and compliance checks; identify discrepancies and escalate them appropriately.
  • Expertise in clinical trial processes, operations, and oversight in biotechnology, pharmaceutical, or contract research organization environments.
  • Strong skills using Microsoft Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support.
  • Working knowledge of clinical trial management systems, electronic trial master files, electronic data capture, and Microsoft Office tools; ability to maintain accurate and timely data entry and manage clinical trial data flow, investigator documentation, and protocol adherence while ensuring regulatory compliance.
  • Experience overseeing vendors and suppliers.
  • Experience executing risk-based site monitoring, audits and inspections, corrective and preventive action implementation, and risk mitigation to resolve operational challenges and ensure inspection readiness.
  • Understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles.
  • Experience tracking and filing essential documents such as protocols, informed consent forms, and regulatory submissions to ensure documents are version-controlled and inspection-ready.

Responsibilities

  • Lead the development and maintenance of study-level trackers, dashboards, timelines, and tools, such as vendor management, sample tracking, and drug supply planning, to ensure accuracy and visibility.
  • Coordinate logistics for investigator meetings, trial events, and site communications.
  • Manage assigned study start-up activities, including system setup, access management, and document readiness, ensuring completion to required standards.
  • Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks.
  • Lead delivery of assigned risk and quality management activities.
  • Track and report study progress, coordinating with the study team and vendors to resolve operational issues and maintain compliance.
  • Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved.
  • Manage study training system activities and oversight.
  • Build and maintain effective relationships with internal study team members, vendors, and investigator sites.
  • Act as a point of contact for routine study updates, ensuring stakeholders are informed and aligned.
  • Identify, prioritize, and escalate risks effectively to support swift, informed decisions.
  • Lead vendors and suppliers set-up to ensure quality, speed, and consistency in deliverables.
  • Maintain and monitor clinical trial systems, such as clinical trial management systems, ensuring accurate and timely data entry and reporting.
  • Support data collection oversight, including query resolution and reconciliation activities.
  • Manage trial documentation, such as the trial master file, to ensure inspection readiness.
  • Contribute to best-practice development, knowledge-sharing, and process improvement within the study support community.
  • Proactively identify and highlight opportunities to streamline or automate activities within remit.
  • Support audits and inspections, including corrective and preventive action processes, and embed lessons learned across studies.

Desired Qualifications

  • Cultural sensitivity and collaboration across global teams.
  • Ability to recognize, highlight, and resolve issues, and demonstrate curiosity and willingness to take on new tasks.

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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