Remote Clinical Trial Manager

Summary

Join our growing team as an experienced Clinical Trial Manager in Australia! Precision for Medicine is a precision medicine CRO that enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology. You will lead CRAs and oversee all clinical aspects of your study across multiple countries, ensuring timeline adherence and scope, whilst ensuring quality delivery.

Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field, including experience in the field of oncology
• Demonstrable experience leading clinical aspects of your studies across multiple countries in a CRO / Pharma or Biotech company (in a dedicated 'clinical lead' role)
• Working knowledge of GCP/ICH guidelines and the clinical development process
• Availability for domestic and international travel including overnight stays
• Demonstrated computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
• Demonstrated ability to develop positive working relationships with internal and external organizations
• Demonstrates core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan

Responsibilities

• Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
• Successful execution of assigned trials and ensuring completion of trial deliverables
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members
• Mentoring and training of team members
• Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
• Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities
• Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction