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Data Delivery Lead

Amgen
5+ 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 Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

Data Delivery Lead

Location: Hyderabad, India
Work Type: On-Site
Department: Clinical Development

Position Summary

The Data Delivery Lead is responsible for the management, oversight, and delivery of clinical trial data across study programs. This role leads end-to-end data management activities, ensuring high-quality, timely, and decision-ready data that supports successful clinical trial execution and regulatory compliance.

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


Key Responsibilities

Study Data Management Leadership

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

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

  • Provide strategic oversight of clinical data management throughout the study lifecycle.

  • Ensure data deliverables are completed according to study timelines and quality standards.


Data Management Planning

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

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

  • Ensure data management strategies align with study protocols, program objectives, and regulatory requirements.

  • Coordinate planning activities with key study stakeholders.


Database Development & Study Setup

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

    • Database Build Activities

    • User Acceptance Testing (UAT)

    • System Validation

    • Go-Live Readiness

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

  • Support implementation of clinical data standards and quality controls.


Study Conduct & Data Review

  • Oversee ongoing data management activities, including:

    • Data Cleaning

    • Query Management

    • Data Reconciliation

    • Data Review Processes

    • Database Lock Preparation

  • Ensure studies remain continuously delivery-ready throughout execution.

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


Data Quality & Performance Monitoring

  • Monitor and evaluate key study 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 and preventive actions to maintain study quality and timelines.


Stakeholder & Vendor Management

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

  • Collaborate with:

    • Clinical Operations Teams

    • Data Management Teams

    • Statistical Programming Teams

    • Clinical Study Teams

    • External Vendors and Service Providers

  • Ensure timely communication, issue resolution, and stakeholder alignment.

  • Manage vendor oversight activities and monitor performance against expectations.


Risk Management & Issue Resolution

  • Identify, assess, and mitigate study-level data risks.

  • Escalate critical issues and delays appropriately.

  • Lead root cause investigations and corrective action planning.

  • Maintain effective issue tracking and resolution processes.


Continuous Improvement

  • Support implementation of best practices and data management standards.

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

  • Contribute to operational excellence and continuous improvement initiatives.

  • Promote innovation and process optimization across study teams.


Basic Qualifications

Candidates must meet one of the following requirements:

  • Doctorate Degree, OR

  • Master's Degree with a minimum of 2 years of experience in Life Sciences, Computer Science, Business Administration, or a related field, OR

  • Bachelor's Degree with a minimum of 4 years of experience in Life Sciences, Computer Science, Business Administration, or a related field, OR

  • Associate Degree with a minimum of 8 years of experience in Life Sciences, Computer Science, Business Administration, or a related field, OR

  • High School Diploma/GED with a minimum of 10 years of experience in Life Sciences, Computer Science, Business Administration, or a related field.


Preferred Qualifications

  • Minimum 5 years of experience in life sciences, healthcare, biotechnology, pharmaceutical, or related industries.

  • At least 3 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

    • Clinical Service Providers

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