Clinical Project Manager

CTI Clinical Trial and Consulting Services; Sydney; Hybrid; AUD 120,000 - 180,000; Full time

Job summary

CTI Clinical Trial and Consulting Services is a global CRO focused on the advancement of treatments for chronically and critically ill patients. The Senior Clinical Trial Manager will lead global trials, ensure GCP/ICH compliance, and coordinate cross-functional teams across regions.

You will manage start-up through analysis phases, oversee budgets and timelines, and serve as the client contact at the operational level. A hybrid work model and remote collaboration are available.

Qualifications

• Bachelor’s degree in allied health fields such as nursing, pharmacy or health science.
• At least 6 years clinical research experience (CRO CRA or Research Manager) or possesses transferable project management experience in a clinical setting.
• Graduate degree preferred.
• At least 5 years of experience with therapeutic focus on rare disease, oncology or cell/gene therapy preferred.
• Experience conducting clinical pharmaceutical research studies in hospital, pharmaceutical company, or CRO settings preferred.
• Previous CRA experience preferred.
• Knowledge of medical and pharmaceutical terminology preferred.
• Experience as Clinical Project Manager or Clinical Trial Manager level position preferred.

Responsibilities

• Plan, implement, evaluate, and complete full execution of assigned clinical trials; often functions as a global trial lead
• Provide oversight and coordination of operational aspects to ensure ICH, GCP, and regulatory compliance
• Manage full scope clinical trial projects from start-up through analysis with multiple projects concurrently
• Coordinate trial activities including timelines, budgets, resources, and scope to meet client expectations
• Maintain trial deliverables and serve as client contact at the operational level
• Oversee contracted vendors and review specifications to meet timelines and quality
• Monitor project tracking and ensure timely data entry for accurate client reporting
• Ensure appropriate training for the trial team and CRA oversight of site management and monitoring

Job description

CTI 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, visit www.ctifacts.com

What You'll Do

• Plan, implement, evaluate, and complete full execution of assigned clinical trials; often functions as a global trial lead
• Set 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 trials
• Provide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures
• Provide 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 simultaneously
• Provide coordination of a clinical trial project including organization, implementation, and management of scoped activities
• Prepare 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 project
• Provide oversight and guidance in the development of trial required deliverables
• Serve as client contact at project operational level
• Provide oversight to contracted vendors; review contracted specifications and maintain regular interactions with vendors to ensure meeting timelines and expectations
• Provide 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 management
• Monitor ongoing resource needs to the project; keep appropriate functional department heads apprised of any identified resource needs or performance issues
• Ensure that assigned clinical trial team receives appropriate training to facilitate effective implementation, conduct and execution of the protocol
• Provide 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 Plan
• Attend site visits on an as-needed basis to provide support to CTI and/or site staff
• Implement project activities according to scope of contracted work
• Evaluate 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 budget
• Assess scope of work against client contractual agreement and inform assigned trial Director of any concerns; facilitate change of scope orders when appropriate
• Lead client and team meetings to enable effective information sharing, discussion and decision-making; ensure accurate and complete documentation of the meeting discussions, decisions and outcomes
• Prepare or provide oversight/approval of weekly and/or monthly project status reports for assigned projects
• Participate and provide oversight in the planning of Investigator meetings; develop and/or approve meeting agendas or related materials and conducts presentations
• Provide 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 Plan
• Participate in business development activities as requested (RFP development, bid defense presentations, client meetings etc.)
• Suggest and participate in process improvement activities and initiatives

What You'll Bring

• You must be fully eligible to live and work in the country you are applying from. CTI does not offer any Sponsorship
• Bachelor’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 experience
• At 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 industry
• Graduate degree preferred
• At least 5 years of experience with therapeutic focus on rare disease, oncology, cell/gene therapy preferred
• Previous technical and managerial experience in conducting clinical pharmaceutical research studies in a hospital setting, a pharmaceutical company, or CRO preferred
• Previous CRA experience preferred
• Experience or education indicating knowledge of medical and pharmaceutical terminology preferred
• Previous experience in a Clinical Project Manager or Clinical Trial Manager level position preferred

Why 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.

Important Note

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process