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Data Management Associate

Amgen
2+ 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: 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

Data Management Associate

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

Position Summary

The Data Management Associate supports the execution of core data management activities across the clinical trial lifecycle, ensuring high-quality, timely, and compliant data delivery. This role contributes to study setup, conduct, and closeout activities while supporting data integrity, regulatory compliance, and successful study outcomes.

The position provides broad exposure to end-to-end clinical data management processes and collaborates closely with cross-functional study teams to support efficient clinical trial execution.


Key Responsibilities

Clinical Data Management

  • Support execution of core data management activities throughout the clinical trial lifecycle.

  • Ensure timely and accurate completion of assigned data management deliverables.

  • Contribute to high-quality and compliant clinical data collection and management processes.

  • Support study teams in achieving data quality and study milestones.


Database Build & Study Setup

  • Assist with database build activities and validation processes.

  • Perform edit check testing and support issue resolution.

  • Support setup and maintenance of:

    • Laboratory Data Configurations

    • Coding Dictionaries

    • Clinical Data Collection Structures

  • Participate in study startup activities and system readiness reviews.


Data Cleaning & Query Management

  • Conduct routine data cleaning activities.

  • Manage and track data queries to ensure timely resolution.

  • Review data for completeness, consistency, and accuracy.

  • Support data review activities and follow-up actions with study stakeholders.

  • Monitor query trends and identify recurring data quality issues.


Data Reconciliation & Database Lock Support

  • Support reconciliation activities across multiple data sources.

  • Assist in identifying and resolving data discrepancies.

  • Contribute to database lock preparation and readiness activities.

  • Ensure study data remains inspection-ready and compliant throughout execution.


Documentation & Compliance

  • Prepare and maintain study documentation, including:

    • CRF Testing Scripts

    • Reconciliation Trackers

    • Data Review Documentation

    • Database Lock Readiness Materials

  • Ensure documentation is complete, accurate, and audit-ready.

  • Adhere to applicable regulatory requirements, SOPs, and internal standards.


Data Quality Monitoring

  • Monitor data quality metrics and query trends.

  • Identify risks, inconsistencies, and process gaps.

  • Escalate issues appropriately and contribute to resolution plans.

  • Support continuous improvement of data quality processes.


Systems & Technology Support

  • Build proficiency in clinical data management systems and tools.

  • Support activities within:

    • Electronic Data Capture (EDC) Systems

    • Clinical Data Management Platforms

    • Data Review Tools

  • Work with systems such as:

    • Veeva Vault

    • Medidata Rave

    • Other Clinical Data Management Technologies


Cross-Functional Collaboration

  • Collaborate with:

    • Data Management Teams

    • Clinical Operations Teams

    • Clinical Study Teams

    • Statistical Programming Teams

    • External Vendors and Partners

  • Support coordinated study execution across multiple stakeholders.

  • Contribute to efficient communication and issue resolution.


Basic Qualifications

  • Bachelor's Degree.

  • Minimum 4 years of clinical execution experience.


Preferred Qualifications

  • Minimum 2 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.

  • Familiarity with industry regulations and data quality standards.