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Medical Monitor

2 hours ago
Australia
Full-time
Mid Level
Operations Specialist
Operations
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986
View All Jobs 28

Description

  • Provide unbiased medical guidance to clinical sites and internal and external study operations teams.
  • Offer therapeutic and compound training and medical guidance on protocol compliance.
  • Ensure medical congruency at both the subject and study level.
  • Oversee coding of medical terms and review study data listings throughout the study lifecycle.
  • Support clinical safety, project management, and data management by reviewing critical study materials at study startup.
  • Review interim or final data sets and assist with writing the final study report.
  • Communicate regularly with the medical team, including participating in medical teleconferences.
  • Interface with internal cross-functional teams and sponsor medical groups throughout the study.
  • Provide medical oversight by answering protocol, eligibility, investigational product, and safety-related questions.
  • Review laboratory values, protocol deviation data, and study-level data to identify safety issues, trends, and follow-up needs.
  • Participate in the development, review, and finalization of protocols, amendments, Clinical Study Reports, and study plans.
  • Provide medical input into data collection tools, feasibility, site selection, site initiation, and medical monitoring plans.
  • Develop and deliver medical training materials, investigator meeting support, and CRA training content.

Requirements

  • Medical degree is required.
  • 4-6 years of related experience is typically expected.
  • Strong understanding of the drug development process, ICH, and Good Clinical Practices (GCP).
  • Strong written and verbal communication skills.
  • Strong presentation skills for engaging with internal teams, clients, and prospective sponsors.
  • Ability to exercise sound clinical judgment in complex or ambiguous trial situations.
  • Strong analytical and critical thinking skills for evaluating patient data and safety signals.
  • Previous clinical trial experience is preferred, especially in a CRO environment.
  • Must be fluent in English.
  • Substantial ongoing job-related training is expected.

Interested in this position?

Apply directly on the company website

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