Clinical Trial Manager

3 days ago

Perth, Western 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. This includes leading the Clinical Trial Team and supporting other development teams as a Clinical Operations representative as required.

Key Responsibilities:
  • Perform day-to-day management and oversight of assigned clinical trials to ensure deliverables are met in all phases of the trial.
  • Lead the Clinical Trial Team and support other development teams as a Clinical Operations representative as required.
  • 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, if applicable, to execute clinical studies.
  • Draft and/or oversee the drafting of site materials, including training, manuals, and support documentation.
  • Review clinical data to ensure timely entry and readiness for data review meetings.
  • Perform periodic review of clinical data, quality metrics, and study deviations.
  • 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, such as the protocol, investigator brochure, regulatory documents, clinical study reports, and other documents and plans as appropriate.
  • Review clinical monitoring reports to ensure timely completion and identification of issues.
  • 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, including multiple regions in global trials.
  • Participate in testing of clinical trial systems/databases (i.e., UAT).
  • Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities.
  • May support additional clinical trials in various capacities (e.g., unblinded clinical trial manager, regional clinical trial manager, etc.).
  • Participate in clinical operations workstreams related to departmental and operating model-related initiatives.
  • Develop and maintain strong, collaborative relationships with key stakeholders within and external to the organization.
  • Strive for continuous improvement and more efficient ways of working in clinical development.
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 to ensure the appropriate conduct of clinical studies.
  • Excellent verbal and written communication skills.
  • Good organizational skills and attention to detail.
What ICON Can Offer You:
  • Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
  • In addition to your competitive salary, ICON offers a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and more.

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