Clinical Trial Operations Manager

4 weeks ago

Canberra, ACT, Australia Pharmiweb Full time
Job Description

The Clinical Trial Manager 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.

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.
  • 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).

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