Senior Clinical Study Manager

7 days ago

Melbourne, Victoria, Australia beBeeClinicalResearch Full time $150,000 - $180,000

Job Summary

  • The successful candidate will be responsible for leading the planning, execution and management of a clinical study for an innovative diagnostic device.

This pivotal role requires a strategic thinker who can oversee all aspects of the trial, from protocol development to participant recruitment and study operations.

Key responsibilities include:

  • Developing and reviewing study protocols for ethics submission
  • Drafting and managing investigational brochures for ethics and regulatory approval
  • Creating and submitting ethics and governance applications and amendments
  • Managing trial documentation, case report forms, reports and essential files
  • Identifying, assessing and overseeing trial sites, including site visits and investigator engagement
  • Overseeing participant recruitment and ensuring study milestones are met
  • Managing study operations, including clinical supply logistics, safety monitoring, adverse event reporting and audits
  • Applying ISO9001 principles and contributing to SOP development and quality documentation
  • Collaborating with research staff, investigators, industry partners and regulatory authorities
  • Leading cross-functional teams, managing timelines, budgets and project deliverables
  • Providing verbal and written reports to management and stakeholders
  • Supporting data management practices, tools and software to ensure compliance
  • Traveling to trial sites and relevant seminars/meetings as required

Our organization is purpose-driven, with a strong alignment to health equity and improving outcomes for vulnerable communities. We have a culture that values inclusiveness, respect, and collaboration.

The ideal candidate will possess a Bachelor of Science/Biomedical Science or related discipline (essential) and minimum 3 years' senior level experience in medical device or diagnostics clinical trials (IVD highly desirable).

What We Offer

A challenging and rewarding career opportunity in a dynamic and supportive environment. We offer competitive compensation and benefits, opportunities for professional growth and development, and a collaborative team atmosphere.

How to Apply

To be considered for this exciting opportunity, please submit your application with a cover letter and resume.

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