Senior Clinical Project Manager

4 days ago

Brisbane, Queensland, Australia Allucent Full time
About the Role

We are seeking a highly skilled and experienced Senior Clinical Project Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for overseeing and managing all aspects of clinical trials from start-up through to final delivery.

Key Responsibilities
  • Strategic Planning: Develop and implement strategic plans for Rare Diseases, Neurology, and Hematology trials, including defining project objectives, timelines, and resource allocation.
  • Trial Management: Oversee the planning, execution, and monitoring of clinical trials, ensuring adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
  • Budget and Resource Management: Manage project budgets and allocate resources effectively. Monitor expenses, identify cost-saving opportunities, and report financial progress to stakeholders.
  • Team Leadership: Lead and supervise a cross-functional team, including clinical research professionals, project managers, and support staff. Foster a collaborative and motivated work environment.
  • Regulatory Compliance: Stay up-to-date with evolving regulatory guidelines and ensure that trials are conducted in compliance with relevant regulations (e.g., FDA, EMA).
  • Risk Management: Identify potential risks and develop risk mitigation plans to ensure trial success and patient safety.
  • Vendor Management: Select, contract, and manage external vendors and partners, such as Contract Research Organizations (CROs) and laboratories, to support trial activities.
  • Data Management: Oversee data collection, analysis, and reporting activities, collaborating with data managers and biostatisticians to ensure data quality and integrity.
  • Safety Monitoring: Implement safety monitoring protocols and procedures, ensuring timely reporting of adverse events and appropriate interventions.
  • Communication: Maintain effective communication with internal teams, external stakeholders, investigators, and regulatory agencies. Provide regular updates on trial progress.
  • Quality Assurance: Implement quality control processes and continuous improvement initiatives to enhance trial quality and efficiency.
  • Documentation: Ensure accurate and comprehensive documentation of all trial-related activities, including study protocols, informed consent forms, and regulatory submissions.
Requirements
  • Education: Bachelor's degree in life sciences or a related field (advanced degree preferred).
  • Experience: Minimum 6 years of relevant work experience.
  • Background: Minimum 6 years of experience in drug development and/or clinical research, with at least 4 years of clinical trial project management involving a range of activities related to patient care, treatment administration, data collection, and ensuring the ethical and regulatory aspects of the trial are met.
  • Skills: Strong knowledge of regulatory requirements and GCP. Excellent project management, leadership, and communication skills. Ability to analyze complex data and make informed decisions. Excellent written and verbal communication, planning, critical thinking, and organizational skills, including command of English language.

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