Clinical Project Manager

Prolong Pharmaceuticals is currently developing a novel biologic PP-007, for the treatment of Acute Ischemic Stroke (AIS) and plans to initiate a Global Phase 3 pivotal study. The Clinical Project Manager will coordinate and manage core operational activities required to execute the study. The ideal candidate brings strong clinical research experience, attention to detail, and the ability to manage complex workflows in a fast-paced environment.

Essential Duties and Responsibilities:

• Drive site feasibility & qualification activities with the CRO and internal teams.
• Manage site activation strategy
• Implement operational planning, set-up and execution of all aspects of the study, while ensuring timely deliverables, in compliance with ICH-GCP and Regulatory standards.
• Lead development of all study-related documents, including EDC design, study plans & other documents per study requirements.
• Monitor & report progress of the clinical study, including budgets & timelines on a regular basis.
• Verify availability of resources at CRO & sites for a smooth conduct of clinical study.
• Confirm sites meet their recruitment commitments, data quality standards and protocol compliance. Proactively monitor protocol deviations and take appropriate steps to re-train sites and mitigate non-compliance.
• Identify, assess and mitigate risks proactively, throughout the course of the study, using risk-based approaches
• Serve as the point-of-contact for the CRO, vendors, sites & investigators.
• Contribute to other assigned tasks as deemed necessary to meet Departmental & Organizational objectives.