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Senior Associate-Clinical Operations-New-I-At-Elanco

Elanco
2+ years
8 LPA - 14 LPA
Bangalore, India
1 June 22, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance

Senior Associate – Clinical Operations (R&D Quality Systems & Global Training)

Location: Bangalore, India
Company: Elanco
Department: R&D Quality Systems & Global Training
Employment Type: Full-Time


Role Summary

The Senior Associate – Clinical Operations is responsible for supporting and executing Elanco’s global R&D Quality Management System (QMS) and Training Framework to ensure compliance, inspection readiness, and operational excellence across global R&D functions.

The role focuses on quality systems administration, training compliance, document management, audit support, regulatory compliance, Power BI reporting, and stakeholder engagement while leveraging digital technologies and AI-enabled solutions to enhance operational efficiency and compliance visibility.


Key Responsibilities

Quality Management System (QMS) Operations

  • Independently manage R&D Quality Management System activities.

  • Monitor compliance metrics, document tracking, and status reporting.

  • Support implementation and maintenance of quality processes.

  • Ensure quality records remain accurate, complete, and audit-ready.

Global Training Administration

  • Execute and support the Global Quality Training System.

  • Ensure:

    • Right Training

    • Right Employee

    • Right Timing

  • Monitor training completion and compliance status.

  • Maintain training records within Learning Management Systems (LMS).

  • Support onboarding and continuous learning initiatives.

Document Management & Control

  • Maintain document control processes within:

    • Veeva Quality Vault

    • SuccessFactors

    • Other R&D Quality Systems

  • Develop and maintain:

    • Job Aids

    • Work Instructions

    • Operational Documents

    • Training Materials

  • Ensure documentation follows quality and regulatory requirements.

Data Analytics & Compliance Reporting

  • Utilize Power BI to:

    • Create Compliance Dashboards

    • Track Training Metrics

    • Monitor Quality Performance

    • Identify Compliance Trends

  • Generate reports for R&D leadership.

  • Support compliance gap analysis and performance monitoring.

AI & Digital Enablement

  • Apply AI-enabled solutions to improve productivity and reporting efficiency.

  • Support adoption of digital tools for compliance monitoring.

  • Utilize technology to streamline quality and training operations.

Audit & Inspection Support

  • Support internal audits and regulatory inspections.

  • Provide organized documentation and compliance evidence.

  • Assist with audit preparation and inspection readiness activities.

  • Support responses to audit observations and compliance actions.

System Administration

  • Serve as a key user and administrator for:

    • Veeva Quality Vault

    • SuccessFactors

    • Power BI

    • Adobe Acrobat

    • Microsoft Office Applications

  • Maintain system data integrity and compliance.

  • Provide user support and guidance.

Cross-Functional Collaboration

  • Collaborate with:

    • Clinical Operations

    • R&D Teams

    • Regulatory Affairs

    • Quality Assurance

    • Global Stakeholders

  • Align deliverables across functions.

  • Facilitate effective communication and issue resolution.

Continuous Improvement & Operational Excellence

  • Identify process improvement opportunities.

  • Support implementation of operational excellence initiatives.

  • Contribute to quality system enhancements.

  • Drive efficient and compliant execution of assigned responsibilities.


Required Qualifications

Education

  • Bachelor’s Degree in:

    • Life Sciences

    • Pharmacy

    • Biotechnology

    • Clinical Research

    • Business Administration

    • Related Scientific Discipline


Experience

  • 2+ years of experience in:

    • Clinical Operations

    • Quality Systems

    • Document Management

    • Regulatory Compliance

    • Training Administration

    • Regulated Environments

Preferred Experience

  • Experience supporting:

    • Clinical Research

    • R&D Operations

    • Pharmaceutical or Biotechnology Industries

    • Quality Management Systems (QMS)