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Study Data Delivery Mgr

Amgen
Amgen
5+ years
Not Disclosed
Hyderabad
10 May 7, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Study Data Delivery Manager


Company

Amgen


Location

Hyderabad, India


Work Type

On-site


Category

Clinical / Data Management


About the Company

Amgen is a global biotechnology company focused on discovering, developing, manufacturing, and delivering innovative medicines for serious illnesses. The company operates across key therapeutic areas including Oncology, Inflammation, General Medicine, and Rare Diseases, aiming to improve patient outcomes worldwide.


Role Summary

The Study Data Delivery Manager is responsible for end-to-end clinical trial data management and oversight. The role ensures high-quality, timely, and decision-ready clinical data across studies and programs, enabling successful clinical development and regulatory outcomes.

This position acts as the single accountable leader for study-level data delivery, ensuring cross-functional alignment and execution.


Key Responsibilities

Study Data Leadership

  • Serve as the single accountable owner for study-level data management

  • Drive data quality, delivery timelines, and cross-functional alignment globally and locally


Planning & Strategy

  • Develop and execute:

    • Data Management Plan (DMP)

    • Integrated Data Review Plan (IDRP)

  • Align data strategy with study protocol and program objectives


Database Design & Setup

  • Lead database build activities in collaboration with technical teams

  • Oversee User Acceptance Testing (UAT)

  • Ensure database readiness and go-live approval


Study Execution & Data Operations

  • Monitor and manage:

    • Data cleaning activities

    • Query management

    • Data reconciliation

    • Database lock readiness

  • Ensure continuous “delivery-ready” data status throughout the study


Data Monitoring & Metrics

  • Track key data performance indicators:

    • eCRF completion rates

    • Non-CRF data flow

    • Query aging

    • Reconciliation backlog

    • Key Risk Indicators (KRIs)

  • Proactively resolve data quality and delivery issues


Stakeholder & Vendor Management

  • Collaborate with global clinical trial teams across geographies

  • Manage external vendors including:

    • CROs

    • Central laboratories

    • Imaging vendors

  • Ensure vendor deliverables meet quality and timeline expectations


Quality & Delivery Oversight

  • Ensure high-quality clinical data for analysis and regulatory submission

  • Lead issue resolution and risk mitigation activities

  • Ensure timely database lock and data readiness for study milestones


Required Qualifications (Basic Eligibility)

One of the following combinations:

  • Doctorate degree
    OR

  • Master’s degree + 2 years experience
    OR

  • Bachelor’s degree + 4 years experience
    OR

  • Associate degree + 8 years experience
    OR

  • High school diploma + 10 years experience

Fields:

  • Life Sciences

  • Computer Science

  • Business Administration or related fields


Preferred Experience

  • 5+ years in life sciences or healthcare domain

  • At least 3 years in biopharmaceutical clinical research

  • Experience working on global clinical trials

  • Experience with CROs or pharmaceutical companies

  • Experience managing external vendors (CROs, labs, imaging, etc.)


Key Skills

  • Clinical trial data management expertise

  • Cross-functional leadership in global teams

  • Vendor management and oversight

  • Strong understanding of clinical data flow and systems

  • Analytical thinking and problem-solving

  • Strong communication and stakeholder management

  • Ability to manage multiple priorities in a global environment


Work Environment

  • On-site role in Hyderabad

  • Global collaboration across time zones

  • High responsibility leadership position in clinical data operations


Core Purpose of Role

To ensure complete, accurate, and high-quality clinical trial data delivery by leading study-level data management activities and enabling successful regulatory and clinical decision-making.