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Study Delivery Sr Associate

Amgen
Amgen
3+ years
Not Disclosed
10 Jan. 6, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Study Delivery Senior Associate – Clinical Research | Hyderabad, India

Company: Amgen | Location: Hyderabad, India | Job Type: Full-Time, On-Site | Job ID: R-232840


About Amgen

Amgen is a global biotechnology leader leveraging biology and technology to develop innovative medicines that address some of the world’s most challenging diseases. With over 40 years of pioneering research, Amgen remains at the forefront of science, using cutting-edge technology and human genetic data to improve patients’ lives worldwide.


Role Overview

Amgen is seeking a Study Delivery Senior Associate (SDSA) to provide critical support in global clinical study management. This role ensures timely, high-quality, and compliant execution of clinical trials while collaborating with study managers, internal teams, vendors, and investigator sites. The SDSA will own study-specific tasks, support risk monitoring, and escalate operational challenges with proposed solutions.

This role offers exposure to global clinical trials and opportunities to contribute to various study processes across the study lifecycle.


Key Responsibilities

Study Planning & Coordination

  • Develop and maintain study trackers, dashboards, and timelines for operational visibility.

  • Coordinate logistics for investigator meetings, trial events, and site communications.

  • Manage start-up activities, including system setup, access management, and document readiness.

Study Execution & Oversight

  • Monitor enrollment, data flow, and quality indicators using study dashboards and reports.

  • Track progress, resolve operational issues, and ensure compliance with global standards.

  • Deliver risk and quality management activities, contributing to global recruitment and retention strategies.

Stakeholder Engagement & Collaboration

  • Serve as a primary contact for routine study updates and align stakeholders.

  • Build strong relationships with internal teams, vendors, and investigator sites.

  • Identify, prioritize, and escalate risks with proactive mitigation strategies.

Site & Vendor Management

  • Lead vendor setup and oversight to ensure consistency and quality of deliverables.

Data & Systems Management

  • Maintain clinical trial systems (CTMS, EDC, eTMF) with accurate and timely data entry.

  • Oversee query resolution, data reconciliation, and document management to ensure inspection readiness.

Process Improvement & Knowledge Sharing

  • Contribute to best practices, knowledge sharing, and continuous process improvement.

  • Support audits, inspections, and CAPA implementation, embedding lessons learned across studies.


Basic Qualifications & Experience

  • Master’s degree OR

  • Bachelor’s degree with 2 years of clinical execution experience OR

  • Associate’s degree with 6 years of clinical execution experience OR

  • High school diploma / GED with 8 years of clinical execution experience


Preferred Qualifications & Experience

  • 3+ years’ experience in life sciences or medically related fields, including at least 1 year in biopharmaceutical clinical research.

  • Experience working on global clinical trials.

  • Strong understanding of clinical trial operations, documentation, and compliance in biotech, pharmaceutical, or CRO environments.


Core Competencies

  • Expertise in clinical trial processes, operations, and oversight.

  • Proficiency with CTMS, eTMF, EDC, Microsoft Office (Word, Excel, PowerPoint).

  • Experience managing vendors, risk-based site monitoring, and CAPA processes.

  • Strong communication, collaboration, and stakeholder management skills.

  • Cultural sensitivity and ability to work effectively with global teams.

  • Attention to detail with the ability to ensure inspection-ready trial documentation.

  • Proactive problem-solving, curiosity, and willingness to take on new responsibilities.


Why Join Amgen?

  • Work with a global biotech leader driving innovation and patient impact.

  • Exposure to cutting-edge clinical research and global study management.

  • Opportunity to collaborate with multicultural teams and develop specialized skills in clinical trial operations.


Equal Opportunity Employer

Amgen is committed to diversity, equity, and inclusion. We provide reasonable accommodations for applicants with disabilities and consider all candidates without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.


Apply Now to join Amgen’s clinical research team in Hyderabad and contribute to life-changing innovations in biotechnology.