Clinical Project Manager in at Prolong Pharmaceuticals LLC

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.

Qualifications and Requirements:

• Bachelor’s degree in nursing, Pharmacy, or health/life sciences. Advanced degree (PhD, Pharm.D.) desirable.
• 8+ years of overall experience in the Pharmaceutical/Biotechnology industry required, with 5+ years of project management experience in managing global Phase 3 studies, including Stakeholder and vendor management.
• Bachelor’s degree in nursing, Pharmacy, or health/life sciences. Advanced degree (PhD, Pharm.D.) desirable.
• Project Management experience across different geographies (North America, EU and/or Asia-Pacific) & time-zones is required.
• Prior CRA experience in-patient Oncology and/or Neurology studies, preferably in a clinical study with a New Biological Entity (NBE).
• Strong understanding of ICH-GCP regulations and Regulatory guidelines.
• Experience working in both – Sponsor and CRO setting preferred.
• Must have good problem-solving, communication and organizational skills.
• Ability to manage multiple priorities and maintain Inspection Readiness. Prior experience of successfully navigating FDA/EMA inspections is required
• Serves as POC for all sites, vendors and cross-functional teams.
• Candidate should have experience working with multiple EDC, eTMF, IWRS platforms
• Proficiency in basic computer applications. Experience in MS Project desirable.
• Clinical certifications (ACRP, SOCRA) or PMP certification is desirable.

Reporting and Work Environment

• Ability to travel as needed.