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Study Delivery Associate

Amgen
Amgen
1-4 years
preferred by company
10 Jan. 6, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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 Associate – Clinical Research

Location: Hyderabad, India
Work Type: On-site
Job Type: Full-Time
Job ID: R-232851
Industry: Clinical Research | Biotechnology | Pharmaceuticals
Experience Required: 1–4 Years (clinical research / trial operations)


About Amgen

Amgen is a global biotechnology leader focused on discovering, developing, manufacturing, and delivering innovative medicines that address some of the world’s most complex diseases. With more than four decades of scientific leadership, Amgen combines advanced biology, data science, and cutting-edge technology to improve patient lives worldwide.


Role Overview

The Study Delivery Associate plays a critical operational and administrative role in supporting global clinical trial execution. This position works closely with the Study Delivery Team to ensure studies are delivered on time, in compliance with regulatory requirements, and aligned with standardized clinical trial processes. The role involves coordination, system and document management, vendor and site support, and maintenance of accurate clinical trial data.

This opportunity is ideal for professionals seeking hands-on experience in global clinical research operations within a leading biopharmaceutical organization.


Key Responsibilities

Study Coordination & Trial Support

  • Support setup and maintenance of study-level trackers, dashboards, timelines, and deliverables

  • Communicate study progress, milestones, and risks to the Study Delivery Manager

  • Track study actions, risks, and mitigation plans and support quality review documentation

  • Assist in ensuring study team training completion and inspection readiness

  • Support global investigator meetings, site communications, and trial-related logistics

  • Contribute to study start-up activities including system access, document readiness, supplier onboarding, and ICF tracking

  • Support vendor coordination and site engagement activities

  • Manage shipment, reconciliation, and analysis of biological samples

  • Coordinate investigational product logistics in compliance with reconciliation and regulatory standards

Data & Clinical Systems Management

  • Maintain accurate and timely data in clinical trial systems such as CTMS and study training platforms

  • Support system access requests and access management activities

Documentation & Trial Master File (TMF)

  • Assist in the preparation, review, and maintenance of clinical trial documentation including monitoring plans, regulatory submissions, and study guides

  • Support TMF filing to ensure inspection-ready documentation

Process Improvement & Knowledge Sharing

  • Contribute to continuous process improvement initiatives

  • Share operational knowledge and best practices across study teams


Required Qualifications & Experience

  • Education (any one of the following):

    • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field

    • Associate degree with 4 years of clinical trial execution experience

    • High school diploma/GED with 6 years of clinical trial execution experience

  • Experience:

    • Minimum 1–2 years of experience in life sciences or medically related roles

    • At least 1 year of biopharmaceutical clinical research experience within a pharmaceutical, biotechnology, or CRO environment preferred

    • Experience supporting global clinical trials is an advantage


Required Skills & Competencies

  • Strong understanding of clinical trial operations and regulatory compliance

  • Working knowledge of CTMS, eTMF, EDC, and clinical trial documentation workflows

  • Proficiency in Microsoft Word, Excel, PowerPoint, and related documentation tools

  • Ability to maintain accurate, timely, and compliant clinical trial data

  • Experience managing investigator documentation, protocol adherence, and regulatory records

  • Strong organizational skills with attention to detail and inspection readiness

  • Ability to collaborate effectively across culturally diverse, global teams

  • Proactive mindset with problem-solving capabilities and willingness to learn new processes


SEO & GEO Optimized Keywords

Study Delivery Associate Jobs India, Clinical Research Jobs Hyderabad, Amgen Clinical Trials Careers, Clinical Operations Associate India, CTMS eTMF Jobs India, Biopharmaceutical Research Jobs Hyderabad.


Equal Opportunity Statement

Amgen is an Equal Opportunity Employer and is committed to creating an inclusive and diverse workplace. All employment decisions are based on business requirements, merit, and qualifications without discrimination of any kind. Reasonable accommodations are provided for individuals with disabilities throughout the hiring process.