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Data Delivery Lead

Amgen
8-15 years
Not Disclosed
Hyderabad
1 June 3, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

Data Delivery Lead

Location: Hyderabad, India
Work Type: On-Site

Position Summary

The Data Delivery Lead is accountable for the management, oversight, and delivery of clinical study data throughout the study lifecycle. This role leads end-to-end data management activities, ensuring the availability of high-quality, timely, and decision-ready data that supports successful clinical trial execution.

The position serves as the primary study-level data management lead, driving operational excellence, data quality, risk management, and cross-functional collaboration across global clinical development teams.


Key Responsibilities

Study Data Management Leadership

  • Serve as the single accountable leader for study-level data management activities.

  • Drive data quality, delivery timelines, and cross-functional alignment across global study teams.

  • Lead end-to-end clinical data management activities throughout the study lifecycle.

  • Ensure data deliverables meet study objectives, quality standards, and regulatory requirements.


Data Management Planning

  • Lead the development and execution of the Data Management Plan (DMP).

  • Develop and maintain the Integrated Data Review Plan (IDRP).

  • Align data management strategies with study protocols and overall program objectives.

  • Ensure appropriate planning for data collection, review, reconciliation, and database lock activities.


Database Development & Implementation

  • Partner with Database Design and Data Acquisition teams to support:

    • Database Build Activities

    • User Acceptance Testing (UAT)

    • Database Go-Live Readiness

  • Ensure study databases are configured and validated according to protocol requirements.

  • Support implementation of data standards and quality controls.


Study Conduct & Data Review

  • Oversee ongoing study data management activities, including:

    • Data Cleaning

    • Query Management

    • Data Reconciliation

    • Data Review Processes

    • Database Lock Preparation

  • Ensure studies remain continuously delivery-ready throughout the trial lifecycle.

  • Drive timely resolution of data-related issues and discrepancies.


Data Quality & Performance Monitoring

  • Monitor and analyze key study performance metrics, including:

    • Electronic Case Report Form (eCRF) Completion

    • Non-CRF Data Collection

    • Query Aging

    • Reconciliation Backlogs

    • Key Risk Indicators (KRIs)

  • Identify risks, trends, and operational challenges proactively.

  • Implement corrective actions to maintain study timelines and data quality objectives.


Stakeholder & Vendor Management

  • Lead study-level data deliverables and cross-functional coordination activities.

  • Collaborate with:

    • Clinical Operations Teams

    • Data Management Teams

    • Statistical Programming Teams

    • Clinical Study Teams

    • External Vendors

  • Ensure timely follow-up and resolution of data-related issues.

  • Provide regular updates regarding study progress, risks, and mitigation plans.


Risk Management & Issue Resolution

  • Identify, assess, and mitigate study data risks.

  • Escalate critical issues and delays appropriately.

  • Lead root cause investigations and corrective action planning.

  • Ensure effective issue tracking and resolution throughout the study lifecycle.


Continuous Improvement

  • Contribute to process optimization and operational excellence initiatives.

  • Support implementation of data management best practices and standards.

  • Identify opportunities to improve efficiency, quality, and scalability of data management processes.

  • Promote a culture of continuous improvement and innovation.


Required Qualifications

  • Bachelor's Degree in Life Sciences, Computer Science, Health Sciences, Business Administration, or a related field.

  • Significant experience in clinical research, clinical data management, or clinical trial operations.


Preferred Qualifications

  • 8–15 years of experience in life sciences, healthcare, biotechnology, pharmaceutical, or related industries.

  • Minimum 5 years of biopharmaceutical clinical research experience gained within:

    • Biotechnology Companies

    • Pharmaceutical Organizations

    • Contract Research Organizations (CROs)

  • Experience supporting and delivering global clinical trials across multiple regions and geographies.

  • Experience managing and overseeing external vendors, including:

    • CROs

    • Central Laboratories

    • Imaging Vendors

    • Data Service Providers

  • Strong understanding of end-to-end clinical data management processes.