Clinical Project Manager

Apply for the Clinical Project Manager role at CTI Clinical Trial and Consulting Services

CTI Clinical Trial and Consulting Services is 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. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.

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• Plan, implement, evaluate, and complete full execution of assigned clinical trials; serve 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.
• Provide oversight and coordination of operational aspects of functional areas to ensure compliance with International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), applicable regulatory guidelines and trial procedures.
• Manage full‑scope clinical trial projects including global trials from start‑up through analysis phase; oversee functionally assigned team members and effectively manage multiple projects simultaneously.
• Coordinate clinical trial projects, including organization, implementation, and management of scoped activities.
• Prepare or oversee development of trial plans, timelines, schedules, resources, and budgets; work with team and trial director to solve challenges that arise during the project.
• Guide development of trial‑required deliverables.
• Serve as client contact at the operational level.
• Oversee contracted vendors; review specifications and maintain regular interactions to ensure timelines and expectations are met.
• Maintain appropriate project tracking using computer‑assisted programs and ensure timely entry of project information to enable accurate reporting.
• Monitor ongoing resource needs; keep functional department heads apprised of any identified needs or performance issues.
• Ensure the clinical trial team receives appropriate training to facilitate effective implementation, conduct and execution of the protocol.
• Oversee Clinical Research Associate (CRA) tasks; manage site monitoring, review site trip reports, and escalates site issues as needed.
• Attend site visits on an as‑needed basis to support CTI and/or site staff.
• Implement project activities according to scope of contracted work.
• Evaluate and manage project budget against milestones and scope; collaborate with the trial director to take corrective measures.
• Assess scope of work against client agreement and inform the trial director of any concerns; facilitate change‑of‑scope orders when appropriate.
• Lead client and team meetings to enable effective information sharing, decision‑making; ensure accurate documentation of discussions, decisions and outcomes.
• Prepare or oversee approval of weekly and/or monthly project status reports.
• Participate and provide oversight in planning of Investigator meetings; develop and approve agendas and related materials; conduct presentations.
• Manage the Trial Master File (TMF) for assigned studies ensuring regular audits and document submission.
• Participate in business development activities as requested (RFP development, bid defense presentations, client meetings, etc.).
• Suggest and participate in process improvement activities and initiatives.

• 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 work experience.
• At least 6 years of clinical research experience (e.g., CRO CRA, Research Manager, Site Research Manager, Central Clinical Research Laboratory Manager) or transferable project‑management skills in a clinical setting.
• Graduate degree preferred.
• At least 5 years of experience focusing on rare disease, oncology, cell/gene therapy.
• Previous technical and managerial experience…