Clinical Project Manager

Ctifacts; Sydney; Hybrid; AUD 110,000 - 170,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Job summary

CTI Clinical Trial and Consulting Services is seeking a senior Clinical Project Manager to lead global trials from start-up through analysis. The role requires oversight of cross-functional teams, adherence to ICH and GCP, and effective vendor and site management.

The ideal candidate has 6+ years in clinical research, a relevant Bachelor's degree, and experience in CRO or hospital settings. Hybrid work options are available, with a focus on delivering high-quality trial outcomes.

Qualifications

• Bachelor's degree in allied health fields or equivalent
• At least 6 years clinical research experience in CRO/clinical setting
• Experience with regulatory guidelines (ICH, GCP) and trial procedures
• Knowledge of medical and pharmaceutical terminology
• Previous Clinical Project Manager/Trial Manager experience preferred
• Previous CRA experience preferred and beneficial

Responsibilities

• Plan, implement, evaluate, and complete full execution of assigned clinical trials; often functions as a global trial lead
• Provide oversight to trial teams to meet timelines and quality
• Ensure compliance with ICH, GCP, and regulatory guidelines
• Manage global trials from start-up through analysis
• Coordinate trial activities, budgets, and resources with trial Directors
• Develop trial plans, timelines, and deliverables; solve challenges with the team
• Oversee vendor interactions and site monitoring activities
• Maintain trial documentation and TMF in accordance with plan
• Lead client and team meetings and provide status reports
• Support business development activities as needed

Skills

Clinical trial management

Project management

Regulatory compliance

Vendor management

Leadership

Education

Bachelor's degree in allied health fields

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
• 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.