Clinical Project Manager (OFFICE)

Company Description

CinRx Pharma is a multi-asset, portfolio biotech company headquartered in Cincinnati, Ohio, focusing on advancing high-impact medicines through clinical development with a unique hub-and-spoke model. The company addresses areas of high unmet medical need including cardio-metabolic, inflammation, gastrointestinal and more. CinRx identifies, funds, and accelerates promising drugs with the potential to have a significant impact on patients' quality of life.

Role Description

This is a full-time on-site role for an experienced and enthusiastic Clinical Project Manager at CinRx Pharma in Cincinnati, OH. The Clinical Project Manager will be responsible for trial management, clinical operations, project management, vendor oversight, research, protocol development, and other tasks as assigned on a day-to-day basis.

Essential Functions 

• Responsible for the oversight of day-to-day operations for assigned projects. This will focus primarily on Phase I to III clinical trials but may include all phases of drug development from pre-clinical through to later phases.
• Establish effective working relationships with CRO and other required vendors. 
• Responsible for ensuring complete and inspection-ready trial master file throughout the duration of assigned clinical trial(s). 
• Evaluate available key data and metrics on an ongoing basis to identify risks to study/project quality, budget/scope, and timelines. 
• Accountable for developing and managing relevant study-level/project-level plans, timelines, and site budgets, and key performance indicators (with assistance from operations management, as appropriate). 
• Manage, facilitate, and document study team/project team meetings (e.g., meeting agenda, minutes, operational risk, action items and decision logs) to enable effective decision making. 
• Participate in on-site or virtual site qualification, site initiation, co-monitoring, and close-out visits with CRO when required. Review and approve CRO monitoring visit reports. 
• Contribute to program-level strategy, timeline development, trial design and implementation (as applicable). 
• Assist with study drug supply and clinical supply forecasting needs and ongoing inventory management oversight. 
• Collaborate with external vendors and/or internal colleagues to ensure critical timepoints are met for regulatory submissions. 
• Participate in the development and coordination of regulatory documents (eg, IND, DSUR) as assigned. 
• Interface with Portfolio Management, Business Development, and Finance Leads to ensure company assets are managed effectively.