Clinical Trial Operations Manager

5 days ago

Perth, Western Australia Pharmiweb Full time
Job Description

The Clinical Trial Manager (CTM) plays a vital role in managing the operational aspects of clinical studies, ensuring global accountability from the Final Protocol Concept Sheet to the Clinical Study Report (CSR) and results disclosure. The CTM brings operational expertise and cross-functional management to deliver assigned trials on time, within budget, and in compliance with quality standards, SOPs, and regulatory requirements.

Key Responsibilities
  • Team Leadership: Establish and lead the Clinical Trial Team (CTT) in collaboration with the Lead Trial Physician, coordinating with functional leaders to assign team representatives.
  • Trial Execution: Ensure clinical trials comply with protocol requirements, ICH-GCP, and internal procedures. Communicate transparently and collaborate effectively with team members and external partners to achieve trial objectives.
  • Operational Oversight: Oversee cross-functional planning, track study progress, and proactively manage trial deliverables and milestones.
  • Vendor Management: Lead and oversee CROs and other vendors, ensuring compliance with contractual obligations.
  • Risk Management: Identify and mitigate risks, collaborate on solutions, and manage contingency planning. Escalate significant issues as necessary.
  • CRO and Vendor Collaboration: Participate in the evaluation, selection, and contracting of CROs and vendors, ensuring alignment with protocol requirements, budget, and timelines.
  • Training and Meetings: Ensure all team members receive appropriate trial-specific training. Oversee the setup and coordination of Investigator Meetings.
  • Documentation Development: Contribute to the creation of trial-related materials, including protocols, monitoring plans, and patient information documents.
  • Patient-Centric Approach: Act with the goal of minimizing patient and site burden throughout the trial process.
  • Feasibility Management: Oversee country and site feasibility processes, ensuring cross-functional alignment.
  • Product Availability: Ensure timely availability of investigational products at sites and maintain clinical site accountability records.
  • Site Oversight: Conduct site visits, review monitoring reports, and ensure data quality and compliance. Proactively address any issues that arise.
  • Recruitment and Retention: Collaborate with the Site & Patient Engagement team, CROs, and other vendors to develop recruitment and retention strategies that foster positive patient experiences.
  • Adverse Event Reporting: Ensure timely documentation and reporting of adverse events (AEs) and serious adverse events (SAEs), collaborating with regulatory authorities as needed.
  • Trial Master File Management: Maintain and ensure the Trial Master File (TMF) is current and accurate.
  • Inspection Readiness: Collaborate with Quality Assurance to ensure constant readiness for audits and inspections, providing necessary support during these processes.
Requirements
  • Education: Bachelor's degree in a medical or para-medical field (e.g., Biology, Biomedical Sciences, Pharmacy).
  • Experience: A minimum of 5 years of experience in Clinical Operations, including clinical trial management at the global level.
  • Background: Experience in the biotech sector is a plus. Background in rare diseases, autoimmune disorders, or oncology trials is highly desirable.
  • Skills: Strong leadership abilities and effective interpersonal skills to foster internal and external relationships. Excellent organizational skills to manage multiple tasks and prioritize effectively. Proactive problem-solving capabilities, with a focus on identifying and mitigating risks. Strong written and verbal communication skills in a culturally diverse environment. In-depth knowledge of ICH-GCP and other relevant regulations. Proficiency with clinical study management tools (e.g., MS Project, CTMS, TMF).
What We Offer

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, we offer a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a global Employee Assistance Programme.

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