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Senior Clinical Program Manager

1 week ago

Brisbane, Queensland, Australia PSG Global Solutions Full time

Job Summary

The Clinical Program Manager is responsible for the management of Therapeutic Area Programs, ensuring compliance with regulatory requirements and industry standards. This involves working closely with development teams to provide GCP technical guidance and recommendations. The successful candidate will have excellent communication and project management skills, with the ability to coach and educate external sites and cross-functional staff.

Key Responsibilities

- Manage complex Therapeutic Area Programs, including multiple indications, data safety monitoring boards, and endpoint review committees- Provide GCP QA leadership to drug development teams- Act as a quality expert, providing GCP compliance interpretation, consultation, training, and recommendations- Collaborate with external sites and cross-functional staff in global regulatory readiness activities and responses

Requirements

For this role, we are looking for a seasoned Clinical Program Manager with a strong background in GCP quality resource and leadership. The ideal candidate will have experience in managing high-risk programs and coordinating multiple vendors. Excellent communication and project management skills are essential for success in this position.

Benefits

At PSG Global Solutions, we offer a competitive salary and benefits package, including opportunities for professional growth and development.