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. CTMs contribute to delivery of pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites. The CTM provides leadership and direction to the Regional Operating Unit (R/OPU) trial team and is accountable for overall success and delivery of assigned clinical trial(s) according to defined milestones and key performance indicators. They steer and direct clinical trial activities, including patient and site engagement and communication with multiple internal and external stakeholders at a regional, local and global level. The CTM manages the planning, implementation and tracking of the clinical trial process, risk mitigation and coordinates closely with the Clinical Trial Leader (CTL) on all study‑related issues. As leader of the R/OPU trial team, the CTM communicates trial status to stakeholders and escalates issues as appropriate. The role is expected to be on‑site (office) and work from home. The CTM may be required to commute to the client’s office 2–3 times a week (Office location: Sydney). Key Accountabilities Trial Preparation Accountable for trial activities for responsible R/OPU, including verification that the trial is conducted in compliance with GCP‑ICH, local/global regulations, SOPs and the protocol, overseeing CRO and internal team activities. Creation, management and review of the R/OPU trial budget to verify appropriate financial oversight and planning accuracy, with timely budget updates based on trial changes. Ensuring appropriate trial‑specific training of R/OPU internal and external partners in line with the trial training plan. Accurate planning and coordination of operational feasibility of trial timelines for the R/OPU; oversight of trial preparation to verify trial team alignment and progress. Verification and input into country and site‑level feasibility and OPU commitment, finalising and validating site selection using available data sources and local insights/expertise. Development and implementation of country‑level engagement plans, recruitment planning and risk mitigation. Coordination of development of country‑level patient‑facing documents. Front‑loading of activities where possible at the R/OPU level to facilitate efficiencies and speed. Oversight of outsourcing of vendor services in the R/OPU according to operating models and governance. Verification of timely responses to questions from Regulatory Authorities/Ethic Committees and other external stakeholders. Trial Conduct Maintenance of oversight during clinical trial conduct, ensuring adherence to GCP and all regulatory requirements, compliance with SOPs and continuous risk monitoring/mitigation. Collaboration with other functions to verify budget oversight, support regular clinical quality monitoring and safety reporting. Monitoring progress of patient recruitment endpoints and proactive contingency management throughout trial conduct. Support of the CTL during investigator meetings. Establishment and maintenance of relationships with external experts, investigational sites, patient organisations and other stakeholders, ensuring cross‑functional collaboration among Clinical Development & Operations (CD&O) and related functions. Active participation in the CD&O community with a focus on contributing to the CTM network and functional excellence. Trial Closeout and Reporting Verification of timely cleaning and delivery of clinical trial data. Responsibility for timely, complete and compliant archiving of all relevant R/OPU documents in the TMF, including vendor documents. Verification of timely submission of the Clinical Trial Report (CTR) to Regulatory authorities/ethics committees and other stakeholders as required by local regulations. Sharing of trial results with investigational sites and, if applicable, patients. General Accountabilities Building and maintaining engagement with investigators, site staff and patient organisations (POs), in collaboration with other functions, to ensure trial speed and effective start‑up, conduct and close‑out. Coordination and maintenance of relationships with external experts, investigational sites and patient organisations, ensuring cross‑functional collaboration among CD&O and related functions. Support of the CTL to ensure issues are raised to the Evidence team for timely action or mitigation. Leadership Competencies Creates an environment that inspires, motivates and empowers colleagues, promoting a common Clinical Development and Operations (CD&O) identity and accelerating clinical development timelines and value creation for patients. Fosters a learning culture in CD&O regions by encouraging continuous learning, sharing best practices and learning from failures. Embraces innovative technologies and creates a culture that drives empowerment, smart risk taking and a common CD&O identity. Compliance with Parexel Standards Compliance with required training curriculum. Accurate completion of timesheets. Submission of expense reports. Updating of CVs. Maintenance of working knowledge of and compliance with Parexel processes, ICH GCPs and other applicable requirements. Skills Strong clinical trial project management experience with an emphasis on team work to promote high‑performance teams. Desirable experience in therapeutic areas relevant to the client pipeline. Understanding of local/regional major regulations. Familiarity with guidelines and standard of care. Experience working with CROs and POs. Ability to build and maintain strong mutually valuable relationships. Excellent influencing and communication skills. Knowledge and Experience Strong communication skills: demonstrates approach and skills in complex cross‑functional matrix structures, active listening and cultural awareness. Scientific and operational expertise across all aspects of clinical trial planning and execution, including protocol, patients, sites, countries and vendors. Leadership and influence: demonstrates skills in addressing complex situations, confident direction for teams, and visionary thinking. Strategic mindset: future‑focused, creative, courageous and able to navigate ambiguity, integrating study strategy with overall therapeutic area portfolio. Coordination and oversight: collaborative leader demonstrating priority setting, pacing of activities and efficient resource use. Project management: effective planning, prioritisation, and proactive transparency to accomplish business deliverables, with risk‑balanced solutions. Education University degree (e.g., Master’s degree or comparable) with several years of relevant experience in the required area, major focus in biomedical life sciences. #J-18808-Ljbffr