CTI Clinical Trial and Consulting Services – Sydney NSWHybrid1mo ago , from CTI Clinical Trial and Consulting ServicesCTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.
We assist clinical research throughout the lifecycle of development, from drug concept to commercialization.
CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.
For more information, visitWhat You'll DoPlan, implement, evaluate, and complete full execution of assigned clinical trials; often functions as a global trial leadSet goals, provide oversight and foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned clinical trialsProvide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Positive Clinical Practices (GCP), applicable regulatory guidelines and trial proceduresProvide management of a full scope clinical trial projects including global trials from start-up through analysis phase; provide oversight of functionally assigned teams members on clinical trials projects; able to effectively manage multiple projects simultaneouslyProvide coordination of a clinical trial project including organization, implementation, and management of scoped activitiesPrepare or provide oversight to the development of trial plans, timelines, schedules, resources, and budgets; work with team and assigned trial Director to provide effective solutions to challenges that arise during the clinical trial projectProvide oversight and guidance in the development of trial required deliverablesServe as client contact at project operational levelProvide oversight to contracted vendors; review contracted specifications and maintain regular interactions with vendors to ensure meeting timelines and expectationsProvide oversight of appropriate project tracking using computer-assisted programs and ensure timely entry of project information by all trial team members to enable accurate reporting to clients and CTI executive managementMonitor ongoing resource needs to the project; keep appropriate functional department heads apprised of any identified resource needs or performance issuesEnsure that assigned clinical trial team receives appropriate training to facilitate effective implementation, conduct and execution of the protocolProvide oversight of Clinical Research Associate (CRA) tasks on assigned projects; provide oversight of the CRA's management of sites and monitoring of the clinical trial data.
Review and approve site trip reports and escalates site issues as needed to assigned trial Director, CTI executive management and/or client/sponsor in accordance with the trial's Communication PlanAttend site visits on an as-needed basis to provide support to CTI and/or site staffImplement project activities according to scope of contracted workEvaluate and manage project budget against project milestones and scope and collaborate with the assigned trial Director as needed to take corrective measures where necessary to keep project in line with budgetAssess scope of work against client contractual agreement and inform assigned trial Director of any concerns; facilitate change of scope orders when appropriateLead client and team meetings to enable effective information sharing, discussion and decision-making; ensure accurate and complete documentation of the meeting discussions, decisions and outcomesPrepare or provide oversight/approval of weekly and/or monthly project status reports for assigned projectsParticipate and provide oversight in the planning of Investigator meetings; develop and/or approve meeting agendas or related materials and conducts presentationsProvide oversight in the management and maintenance of the TMF for assigned studies ensuring that all trial assigned staff regularly submit documents and complete regular audits of the TMF to ensure accuracy and completeness as defined in the trial's TMF PlanParticipate in business development activities as requested (RFP development, bid defense presentations, client meetings etc.)Suggest and participate in process improvement activities and initiativesWhat You'll BringYou must be fully eligible to live and work in the country you are applying from.
CTI does not offer any SponsorshipBachelor's degree in allied health fields such as nursing, pharmacy or health science, preferably with clinical trial management experience or an equivalent combination of education and relevant work experienceAt least 6 years clinical research experience (CRO CRA or Research Manager, Site Research Manager, Central Clinical Research Laboratory Manager)



or possesses transferrable skills and experience in project management in a clinical setting or relatable industryAt least 5 years of experience with therapeutic focus on rare disease, oncology, cell/gene therapy preferredPrevious technical and managerial experience in conducting clinical pharmaceutical research studies in a hospital setting, a pharmaceutical company, or CRO preferredPrevious CRA experience preferredExperience or education indicating knowledge of medical and pharmaceutical terminology preferredPrevious experience in a Clinical Project Manager or Clinical Trial Manager level position preferredWhy CTI?
Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow.
We also value ongoing education and training through a dedicated training department.Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries.
We support a work-life balance and the importance of time with family by offering hybrid work from home opportunities.
We also encourage care for the world around us through our unique CTI Cares program.Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process.
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📌 Hybrid Global Clinical Trial Lead (Sydney)
🏢 CTI Clinical Trial and Consulting Services
📍 Sydney