Global Trial Management Specialist
4 days ago
The Clinical Operations Director will play a pivotal role in driving the success of our clinical trials in Australia. We are seeking an experienced professional who can develop and implement effective clinical trial strategies and protocols.
Key Responsibilities:
- Developing and implementing clinical trial strategies and protocols to achieve project goals.
- Leading cross-functional teams to ensure successful execution of clinical trials.
- Managing relationships with vendors, CROs, and other external partners to optimize study operations.
- Overseeing study operations, including site selection, regulatory submissions, and data management.
- Preparing and managing budgets, timelines, and forecasts for clinical studies.
- Participating in the development and review of Clinical Operation processes, SOP systems, and initiatives.
- Collaborating with colleagues to ensure successful implementation of program(s)/trial(s).
- Presenting program(s)/trial(s) to senior management, cross-functional teams, and external partners.
- Supporting regulatory activities, including INDs and other regulatory submissions, inspection readiness activities, and serving as a subject matter expert during regulatory inspections.
About You
- Advanced degree in a science or healthcare-related field.
- At least 7 years of experience in clinical operations, preferably in a biotech/pharmaceutical industry setting.
- Strong understanding of clinical trial regulations and ability to apply this knowledge in a real-world setting.
- Exceptional leadership, communication, and problem-solving skills.
- Able to travel extensively for meetings, training, and other business-related purposes.
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