Medical Monitor

2 weeks ago

Sydney, New South Wales, Australia 921 Pfizer Australia Pty Ltd Full time

Role Summary

The clinician medical monitor contributes to providing medical and scientific expertise and oversight for clinical trials conducted worldwide, with a primary focus in Japan and the Asia-Pacific region.

Key Responsibilities

  • Contributes to the medical input during protocol development and updates to the clinical development plan.
  • Works closely with other medical monitors and Japan study team members to ensure that documents meet regulatory requirements and company policy.
  • Provides medical input into country feasibility.

Accountability for Safety

  • Provides study team with medical advice for all medical issues during risk assessment and mitigation planning.
  • Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP).
  • Monitors study safety issues and provides input to serious adverse events (SAEs) reports.

Support to the Study Team

  • Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, and data quality planning.
  • Contributes to contract research organization/vendor selection to ensure study is conducted consistent with protocol requirements.
  • Works with study team to ensure high quality of data.

Interactions with Regulatory Authorities and Key Opinion Leaders

  • May support Clinical Regulatory Authority interactions, particularly with the PMDA.
  • Liaises with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders/Principal Investigators network for new trials.

Qualifications

Must have:

  • Medical degree (M.D or equivalent).
  • Licensed by a health authority to prescribe medicines.
  • Excellent written and oral communication in English and Japanese.
  • Understanding of the design, development, and execution of clinical programs and studies.

Preferred Qualifications

  • Documented work experience/knowledge of statistics.
  • Training and experience in infectious diseases and/or infection control in the hospital setting.
  • Experience with investigational clinical trials.

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