Global Clinical Study Support Specialist (Remote)

Elanco; United States; Presencial; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

Elanco is seeking a Clinical Trials Specialist to drive study acceleration, remote study support, and document management across global teams. The role involves regulatory documentation, study master file oversight, and keeping Veeva and related R&D systems audit-ready.

You will partner with Sponsor Representatives and Global Clinical Leads, manage study tracking, and ensure data integrity throughout the end-to-end lifecycle of trial documentation.

Qualificações

• DVM or PhD with 2+ years clinical research operations experience.
• Understanding of FDA, USDA, EMA, ICH, GLP and GCP guidelines.
• Proven track record in clinical project management and problem-solving.
• Ability to interface with clinical personnel and collaborate with global teams.

Responsabilidades

• Conducts remote support activities and study oversight to ensure compliance and data quality.
• Manages Study Master File (SMF/TMF) and document transfer, ensuring regulatory templates.
• Maintains primary R&D systems (e.g., Veeva) and ensures audit-ready study parameters.
• Proactively tracks global study milestones and provides status reporting to GCLs.
• Prepares regulatory and scientific documents including protocols and Final Study Reports.
• Oversees site contracting and in-life adverse event/PV reporting to meet timelines.

Conhecimentos

Clinical research operations

Scientific writing

Regulatory guidelines

PM & cross-functional leadership

Communication skills

Formação académica

DVM/PhD

Ferramentas

CTMS

Veeva

Microsoft Office

Microsoft Project

Descrição da oferta de emprego

Elanco is seeking a Clinical Trials Specialist to drive study acceleration, remote study support, and document management across global teams. The role involves regulatory documentation, study master file oversight, and keeping Veeva and related R&D systems audit-ready.

You will partner with Sponsor Representatives and Global Clinical Leads, manage study tracking, and ensure data integrity throughout the end-to-end lifecycle of trial documentation.