Clinical Project Manager
1 week ago
Company Description
CinRx Pharma is a biotech company headquartered in Cincinnati, Ohio, focusing on advancing high-impact medicines through clinical development with a unique hub-and-spoke business model. The company addresses areas of high unmet medical need including metabolic, gastrointestinal, and oncology. 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 a Clinical Project Manager at CinRx Pharma in Cincinnati, OH. The Clinical Project Manager will be responsible for trial management, clinical operations, project management, research, and protocol development on a day-to-day basis.
Select, 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.
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