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Precision for Medicine is a clinical research organization (CRO) that combines advanced technologies, scientific expertise, and operational scale to accelerate the development of life-changing therapies. The company specializes in oncology and rare disease clinical trials, integrating clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences.
The Senior Clinical Project Manager will serve as the primary point of contact and escalation point for assigned clinical study projects, ensuring delivery of quality, scope, cost, and timeline objectives. Key responsibilities include:
• Coordinate and oversee all functional services and external vendors to established timelines and budgets
• Manage study budgets independently, ensuring projects remain within scope and identifying out-of-scope activities early
• Maintain integrated collaboration with clinical operations and participate in clinical activities as appropriate
• Manage financial health of assigned studies, including profitability oversight, billable hours tracking, and accurate billing and forecasting
• Develop comprehensive project plans with timelines, proactive risk management, and mitigation strategies
• Ensure quality management for assigned projects, including eTMF inspection readiness and implementation of corrective/preventative action plans
• Establish tracking metrics to monitor trial and team progress toward project goals
• Prepare project status updates and KPI reports for clients and senior management
• Lead internal and client meetings, setting expectations for project teams
• Communicate effectively with clients and Precision management regarding protocol/study issues and deviations
• Conduct formal presentations to colleagues, investigative staff, and clients, including bid defense presentations
• Ensure study-specific training implementation and compliance throughout the project
• Support business development and marketing activities, including travel to bid defense meetings as required
• Provide ongoing feedback to functional team members and conduct annual performance reviews
• Maintain compliance with organizational training, time-reporting, and administrative duties
Requirements:
• Bachelor's degree or equivalent combination of education and experience in science or health-related field (advanced degree preferred)
• Minimum 7 years of clinical research experience with proven competencies for this position
• Minimum 4 years of direct project management experience
• Experience managing complex and global trials
• Ability to travel domestically and internationally including overnight stays
• Proficiency with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and Microsoft Project
• Experience with eTMF, EDC, and CTMS systems
• Proven communication and interpersonal skills for effective team collaboration
• Strong organizational skills, attention to detail, and customer service orientation
• Knowledge of ICH-GCP and relevant SOPs with ability to implement
• Proven knowledge of project management techniques and tools
• Direct work experience in global, cross-functional project management environments
• Understanding of cross-functional management, project planning, risk management, and change management
• High level of integrity and professional/ethical standards
• Ability to lead and inspire excellence within study teams
• Results-oriented, accountable, motivated, and flexible mindset
• Strong time management, negotiation, critical thinking, decision-making, analytical, and interpersonal skills
• Excellent presentation, verbal, and written communication skills
• In-depth proven experience in pharmaceutical and/or device research