Clinical Trial Manager

Parexel, North Ryde, New South Wales, Australia Clinical Trial Manager - FSP The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, set‑up, execution and delivery of assigned clinical trials at the regional/local level. The role contributes to the delivery of Parexel’s pipeline through accurate planning and efficient execution of trials that bring speed and value to participating patients and sites. Key responsibilities include steering and directing clinical trial activities, patient and site engagement, risk mitigation, and close communication with internal and external stakeholders and trial team members at a regional/local and global level. The CTM serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader (CTL) on all study‑related issues, and communicates trial status to stakeholders, escalating issues as appropriate. Location: Must be on‑site (office) with options to work from home. May be required to commute to the client’s office in Sydney 2–3 times a week. Key Accountabilities Trial Preparation Accountable for trial activities for the responsible R/OPU, including compliance with GCP‑ICH, local/global regulations, SOPs and trial protocol. Manage and review the R/OPU trial budget to ensure financial oversight and planning accuracy, with timely updates based on trial changes. Ensure appropriate training of R/OPU internal and external partners in line with the trial training plan. Plan and coordinate operational feasibility of trial timelines, overseeing team alignment and progress. Validate site selection and finalize country‑level engagement, recruitment, and risk‑mitigation plans. Coordinate the development of country‑level patient‑facing documents with internal and external stakeholders. Oversee outsourcing of vendor services in the R/OPU under operating models and governance. Respond timely to queries from regulatory authorities, ethics committees and other external stakeholders. Trial Conduct Maintain oversight during trial conduct, ensuring adherence to GCP, regulations, SOPs and continuous risk monitoring. Monitor patient recruitment progress and proactively update and action contingencies throughout trial conduct. Support CTL during investigator meetings. Maintain relationships with external experts, investigational sites, patient organisations and other stakeholders, ensuring cross‑functional collaboration. Participate in the CD&O community, especially the CTM network, to contribute to functional excellence. Trial Closeout and Reporting Verify timely cleaning and delivery of clinical trial data. Ensure complete, compliant archiving of all relevant R/OPU documents in the TMF, including vendor documents. Submit Clinical Trial Report (CTR) to regulatory authorities, ethics committees and other stakeholders as required. Share trial results with investigative sites and, if applicable, patients. General Accountabilities Build and maintain engagement with investigators, site staff and patient organisations to verify trial speed and effectiveness. Support CTL to raise issues to the evidence team for timely action or mitigation. Leadership Competencies Create an environment that inspires, motivates and empowers colleagues, promoting a common CD&O identity. Foster a learning culture by encouraging continuous learning and sharing best practices. Embrace innovative technologies and cultivate a culture of empowerment and smart risk‑taking. Compliance with Parexel Standards Complete required training curriculum. Submit accurate timesheets and expense reports. Maintain a working knowledge of Parexel processes, ICH GCPs and other applicable requirements. Skills Strong clinical trial project management experience with emphasis on team performance. Desirable experience in therapeutic areas relevant to the client pipeline. Understanding of local/regional major regulations. Familiarity with guidelines and standards of care. Experience working with CROs and POs. Ability to build and maintain strong relationships of mutual value. Excellent influencing, communication, and cultural awareness skills. Knowledge and Experience Demonstrated communication, influencing and alignment skills in complex cross‑functional matrix structures. Scientific and operational expertise across all aspects of clinical trial planning and execution. Leadership and influence in setting direction for teams and delivering value to patients. Strategic mindset with a global perspective, agile problem solving and risk‑balanced solutions. Collaboration and efficient resource management. Effective project management, defining priorities, transparency and proactive risk resolution. Education University degree (e.g., Master’s or comparable) with several years of relevant experience in Biomedical Life Sciences. #J-18808-Ljbffr