Halloran - For Your Development

Clinical Research Operations Management

Overview

Success in the biopharmaceutical industry requires significant clinical operations management skills. The clinical operations team is responsible for performance standards, quality, resource and budget planning, training and development. This course introduces participants to the roles and responsibilities that clinical operations managers and directors should be familiar with when establishing a clinical operations role in a company. The program will include hands-on exercises and case studies that incorporate the concepts taught so that participants may apply new skills back on the job.

Who will benefit

Candidates for this course include individuals new to a role in clinical operations or individuals with some experiences in clinical operations who want to improve their organization's support of the clinical development process such as clinical research associates, clinical operations managers/directors/VPs and executives considering reorganizing to incorporate the clinical operations model.

Key topics

  • Roles an responsibilities
  • Resource allocation and management
  • Key performance indicators
  • Outsourcing strategies and establishing vendor management capabilities
  • Financial consolidation and budgetary planning
  • Creation or improvement of the quality management system: Standard Operating Protocol (SOP) and processes
  • Training and development of the clinical development organization
  • Technical initiatives to support clinical development

Learning outcomes

  • Understanding of roles and responsibilities of a clinical operations management position
  • Knowledge of the competencies for a successful clinical operations manager/director
  • Ability to design a clinical operations plan for a growing clinical department

Click here to learn more about bringing this course in-house.

The Latest

Announcing 2010 public training courses schedule

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Now Available - Your Clinical Research Career Training - Register Today!

"This course provided a great overview and the right level of detail on all areas of vendor management.”

Megan Cisneros, Clinical Project Manager
AMAG Pharmaceuticals
on Managing Outsourced Clinical Trials