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Clinical Research Study Leader

3 weeks ago

Melbourne, Victoria, Australia beBeeClinicalResearchStudy Full time $120,000 - $140,000

Clinical Research Study Leader Job Opportunity

The role of Clinical Research Study Leader involves overseeing global clinical research studies, interacting with sponsors and sites, managing timelines and project deliverables, and coordinating all services contracted for the study.

  • Main Responsibilities:
  • Manage day-to-day operations of the project, ensuring compliance with ICH/GCP regulations.
  • Act 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 ensuring necessary project-specific training.
  • Review and provide input on study protocol, edit check specifications, data analysis plan, and final study report.
  • Develop operational project plans and manage risk assessment and mitigations.
  • Oversee study vendors and site quality, including direct supervision of project Clinical Research Associates (CRA).

Required Skills and Qualifications:

  • Bachelor's degree or above in a health or life science related field.
  • At least two years of clinical trial management experience in the Asia Pacific region; indications of interest a plus.
  • Prior CRO experience preferred.
  • Excellent communication skills, including good verbal and written English.
  • Flexible, accountable, and comfortable working in a global environment.

Benefits of Working in This Role:

This position offers a unique opportunity to lead global clinical research studies, interact with sponsors and sites, and develop operational project plans. The successful candidate will have excellent communication skills, be flexible and accountable, and be comfortable working in a global environment.

Additional Information:

This job description has been rewritten to improve clarity and readability. The required skills and qualifications have been listed separately from the main responsibilities.