Clinical Portfolio Execution Director
vor 8 Stunden
CSL is a global biotechnology leader, driven by a commitment to save and improve lives. Millions of people worldwide live with rare and serious medical conditions. CSL is dedicated to delivering innovative medicines that make a difference in their lives.
As a Director of Clinical Portfolio Execution, you will play a critical role in shaping the company's clinical portfolio strategy. Your primary responsibility will be to establish and manage standards and processes for main study operations activities, ensuring seamless clinical trial support and human biological sample management.
Key responsibilities include:
- Establishing and managing standards and processes for main study operations activities.
- Facilitating global resourcing for clinical portfolio execution roles to support the Head, CPE in ensuring appropriate and resource allocation aligned with project priorities.
- Utilizing lessons learned from prior study conduct, site visits, audits, and inspections to develop and implement process improvements.
- Leading CPE capability building by supporting onboarding and ensuring harmonization of practice at the study level.
- Setting up and making the interface with any Functional Service provider for study delivery activities.
- Responsible for quality practices, management monitoring, control documents development, improvement support, and training related to Study Delivery roles People Management.
Requirements:
- Bachelor's degree in Science or Pharmacy.
- 12 or more years of relevant clinical research (or related) experience in the pharmaceutical industry.
- Understanding of the drug development process, and specifically, each step within the clinical trial process.
- Experience in study management, clinical-ops, human biological sample management, and related process development.
- Knowledge of ICH GCP, FDA GCP Regulations, and EU clinical trials directives.
CSL employees who work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.
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