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Clinical Project Manager II or higher Australia
1 month ago
Job Category: Clinical Project Management
We are a global, privately held, full-service clinical contract research organization (CRO) focused on advancing treatments for chronically and critically ill patient populations.
We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. Our team is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.
Key Responsibilities:
- 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.
- Manage multiple clinical trial projects simultaneously, providing oversight of functionally assigned teams members and effectively managing project resources.
- Coordinate clinical trial projects, including organization, implementation, and management of scoped activities.
- Prepare or provide oversight to the development of trial plans, timelines, schedules, resources, and budgets.
- Serve as client contact at project operational level.
- Oversight of contracted vendors, review contracted specifications, and maintain regular interactions with vendors to ensure meeting timelines and expectations.
- Track project progress using computer-assisted programs and ensure timely entry of project information by all trial team members.
- Monitor ongoing resource needs to the project and 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.
- Oversight of Clinical Research Associate (CRA) tasks on assigned projects, review and approve site trip reports, and escalate site issues as needed.
- Attend site visits as needed to provide support to CTI and/or site staff.
- Evaluate and manage project budget against project milestones and scope, collaborating with the assigned trial Director as needed to take corrective measures where necessary.
- Assess scope of work against client contractual agreement and inform assigned trial Director of any concerns, facilitating change of scope orders when appropriate.
- Lead client and team meetings to enable effective information sharing, discussion, and decision-making.
- Prepare or provide oversight/approval of weekly and/or monthly project status reports for assigned projects.
- Participate in planning Investigator meetings, develop meeting agendas, and conduct presentations.
- Oversee the management and maintenance of the TMF for assigned studies, ensuring accuracy and completeness as defined in the trial's TMF Plan.
- Participate in business development activities as requested.
Requirements:
- Fully eligible to live and work in Australia; CTI does not offer 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 of clinical research experience (CRO CRA or Research Manager, Site Research Manager, Central Clinical Research Laboratory Manager) or possesses transferable skills and experience in project management in a clinical setting or relatable industry.
- 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.
- CRA experience preferred.
- Experience or education indicating knowledge of medical and pharmaceutical terminology preferred.
- Clinical Project Manager or Clinical Trial Manager level position preferred.
About Us:
- Advance Your Career – We support career progression through a structured mentoring program and leadership courses.
- Join an Award-Winning Team – We have an award-winning unparalleled culture across 60 countries.
- Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients.
Note: In light of recent increase in hiring scams, if 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.
