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Data Management Sr Associate

Amgen
6+ 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: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding

Data Management Senior Associate

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

Position Summary

The Data Management Senior Associate is responsible for supporting the delivery of high-quality clinical trial data through the execution of core data management activities across the study lifecycle. This role ensures data integrity, regulatory compliance, and timely study execution while supporting global clinical development programs.

The position collaborates closely with Data Delivery Leads, Database Designers, Data Acquisition Leads, and cross-functional study teams to ensure efficient study conduct and successful data delivery.


Key Responsibilities

Clinical Data Management

  • Execute study-level data management activities with limited supervision.

  • Support clinical studies throughout the data lifecycle, ensuring high-quality and compliant data delivery.

  • Perform data management tasks according to study timelines and quality standards.

  • Ensure adherence to applicable regulatory requirements and company procedures.


Database Build & Testing

  • Support database build activities and validation processes.

  • Perform database testing to ensure system functionality and protocol compliance.

  • Assist in User Acceptance Testing (UAT) and issue resolution.

  • Verify data collection structures and database configurations.


Data Cleaning & Query Management

  • Conduct routine data review and cleaning activities.

  • Manage data queries and follow up with study stakeholders to ensure timely resolution.

  • Identify data discrepancies and coordinate corrective actions.

  • Ensure accurate and complete study data throughout the clinical trial lifecycle.


Data Reconciliation & Database Lock Support

  • Perform reconciliation activities between multiple clinical data sources.

  • Support reconciliation of external and non-CRF data.

  • Assist with database lock preparation activities.

  • Ensure studies remain audit-ready and delivery-ready throughout execution.


EDC & External Data Management

  • Support setup and maintenance of:

    • Electronic Data Capture (EDC) Systems

    • Non-CRF Data Structures

    • Local Laboratory Data Integrations

    • Coding Dictionaries

    • External Data Integrations

  • Monitor data flows and ensure timely ingestion of clinical data.

  • Support data quality checks and integration activities.


Study Tracking & Risk Management

  • Track progress against:

    • Data Management Timelines

    • Study Milestones

    • Deliverables and Deadlines

  • Identify potential risks, issues, and delays.

  • Escalate concerns with appropriate documentation and proposed mitigation strategies.

  • Support proactive issue resolution activities.


Cross-Functional Collaboration

  • Coordinate with:

    • Local Data Management Teams

    • Global Study Teams

    • Clinical Operations Teams

    • Functional Service Providers (FSPs)

    • External Vendors

  • Ensure alignment and timely execution of study deliverables.

  • Support communication and collaboration across multiple stakeholders.


Process Improvement & Knowledge Sharing

  • Identify opportunities to improve operational efficiency and repeatable processes.

  • Contribute to best practices, process optimization, and standardization initiatives.

  • Participate in knowledge-sharing activities and team development programs.

  • Support continuous improvement efforts within the Data Management function.


Basic Qualifications

  • Bachelor's Degree.

  • Minimum 6 years of clinical execution experience.


Preferred Qualifications

  • Minimum 3 years of experience in life sciences, healthcare, biotechnology, pharmaceutical, or related industries.

  • At least 1 year of biopharmaceutical clinical research experience gained within:

    • Biotechnology Companies

    • Pharmaceutical Organizations

    • Contract Research Organizations (CROs)

  • Experience working in Clinical Data Management for global clinical trials.

  • Understanding of clinical trial processes and data management workflows.

  • Experience collaborating with global and cross-functional teams.