Clinical Project Manager **Level Dependent

Clinical Project Manager – Level Dependent on Experience

Join to apply for the Clinical Project Manager – Level Dependent on Experience 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 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.

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• Plan, implement, evaluate, and complete full execution of assigned clinical trials; often functions as a global trial lead.
• Set goals, and timelines, provide oversight and positive leadership to 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.
• Implement project activities according to scope of contracted work.
• Evaluate and manage project budget against project milestones and scope and collaborate with the trial assigned Director as needed to take corrective measures where necessary to keep project in line with budget.
• Regularly assess project profit margins with trial‑assigned Director at the project and project service levels and work with the trial‑assigned Director and project team to understand deficiencies; support and mitigation strategies to positively impact project profit margins.
• Assess scope of work against client contractual agreement and inform trial assigned Director of any concerns; facilitate change of scope orders when appropriate.
• Prepare or provide oversight and support to the development of trial plans, timelines, schedules, resources, and budgets; work with team and trial assigned Director to provide effective solutions to challenges that arise during the clinical trial project.
• Prepare or 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 and management of third‑party vendors’ financial spend.
• Closely review and assess trial’s KPI to ensure project progressing in a positive manner and actively works with team to mitigate activities that are outside the expected ranges.
• 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 the 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 elevate site issues as needed to trial assigned Director, CTI executive management and/or client/sponsor in accordance with the trial’s Project and…