Clinical Trial Manager

4 weeks ago

Melbourne, Victoria, Australia Pharmiweb Full time
Clinical Trial Manager Job Description

As a Clinical Trial Manager at Pharmiweb, you will be responsible for the day-to-day management and oversight of assigned clinical trials to ensure deliverables are met in all phases of the trial. You will lead the Clinical Trial Team and support other development teams as a Clinical Operations representative as required.

Key Responsibilities:
  • Perform and document study-level Sponsor Oversight of outsourced clinical activities
  • Communicate study-status, cost, and issues to ensure timely decision-making by senior management
  • Initiate and manage study-level timelines, including communication to internal and external team members on deliverables
  • Work closely with other supporting clinical operations team members to execute clinical studies
  • Review clinical data to ensure timely entry and readiness for data review meetings
  • Manage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
  • Review and provide clinical operations input into relevant clinical documents
  • Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
  • Complete and maintain internal clinical trial metrics, dashboards, and other internal updates
  • Ensure trial is conducted in accordance with internal and ICH/GCP standards

Requirements:
  • 5-7 years of experience in a clinical research and industry environment, including a minimum of 2+ years of independent trial management
  • Bachelor's degree required; Advanced degree preferred
  • Relevant experience in global settings, across more than one phase of development, and across the entire lifecycle of a study
  • Solid understanding of drug development
  • Infectious Disease experience preferred
  • Good project management skills
  • Good understanding of FDA and ICH GCP guidelines
  • Excellent verbal and written communication skills
  • Good organizational skills and attention to detail

What ICON Can Offer You:
  • Competitive salary
  • Various annual leave entitlements
  • Range of health insurance offerings
  • Competitive retirement planning offerings
  • Global Employee Assistance Programme
  • Flexible country-specific optional benefits

About ICON:
  • Diversity, inclusion, and belonging are fundamental to our culture and values
  • We're proud of our diverse workforce and the work we've done to become a more inclusive organisation
  • We're dedicated to providing an inclusive and accessible environment for all candidates

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