Clinical Trials Manager

2 months ago

Brisbane, Queensland, Australia Allucent Full time
Associate Project Director

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials to bring life-changing therapies to patients in need globally.

We are seeking an Associate Project Director to join our team, responsible for overseeing and managing all aspects of clinical trials from start-up through to final delivery for various therapeutic areas. This role plays a pivotal part in ensuring the successful execution of trials, focusing on safety, regulatory compliance, and efficient project management.

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 (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:
  • Bachelor's degree in life sciences or a related field (advanced degree preferred).
  • Minimum 6 years of relevant work experience.
  • 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.
  • 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 the English language.
  • Representative, outgoing, and client-focused.
  • Ability to work effectively in a fast-paced, challenging environment with a growing company.
  • Proficiency with various applications, including Microsoft Word, Excel, and PowerPoint.
  • Strong presentation skills.
Benefits:
  • Comprehensive benefits package per location.
  • Competitive salaries per location.
  • Departmental Study/Training Budget for furthering professional development.
  • Flexible Working hours (within reason).
  • Opportunity for remote working depending on location.
  • Leadership and mentoring opportunities.
  • Participation in our Buddy Program as a new or existing employee.
  • Internal growth opportunities and career progression.
  • Financially rewarding internal employee referral program.
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms.

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