Pharmaceutical Project Manager
7 days ago
This is an excellent opportunity for a seasoned Clinical Operations Director to join our team in Australia and contribute to the success of our clinical trials.
The ideal candidate will have a strong background in clinical operations, including experience in developing and implementing 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
- Master's degree in a science or healthcare-related field.
- Minimum 8 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.
- Excellent leadership, communication, and problem-solving skills.
- Able to travel extensively for meetings, training, and other business-related purposes.
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