Global Clinical Trial Leadership Role

2 weeks ago

Melbourne, Victoria, Australia beBeeClinicalResearch Full time $116,000 - $144,500
Clinical Research Study Manager Position

As a Clinical Research Study Manager, you will be responsible for overseeing the global management of clinical research studies. With a focus on multiservice global/regional trials, you will interact with sponsors and sites, manage timelines and project deliverables, and coordinate all services contracted for the study.

The ideal candidate will have a Bachelor's degree in a health/life science related field and at least two years of clinical trial management experience in the Asia Pacific region. Prior CRO experience is preferred, along with excellent communication skills and flexibility in a global environment.

Key Responsibilities
  • Manage day-to-day operations of the project, ensuring compliance with ICH/GCP and applicable laws, rules, and regulations
  • Serve as primary Sponsor contact for project-specific issues and study deliverables
  • Maintain in-depth knowledge of protocol, therapeutic area, and indication
  • Provide cross-functional oversight of project team members and deliverables, including necessary project-specific training
  • Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable
  • Develop operational project plans and manage risk assessment and mitigations
  • Manage study vendors and site quality, including direct supervision of project Clinical Research Associates (CRA) and monitoring deliverables

This position offers a full-service clinical contract research organization (CRO) committed to accelerating the global development of safe and effective medical therapeutics through our scientific and disciplined approach.

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