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Director, Clinical Trials Project Management - Gladstone New Jersey
Company: Precision Medicine Group Location: Gladstone, New Jersey
Posted On: 01/27/2025
Director, Clinical Trials Project Management at Precision Medicine Group (View all jobs) Remote, United States Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages-from early development through approval-with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won't you join us today as a Director, Clinical Trials Project Management? Position Summary: Works cross functionally to develop partnership strategies for clinical trials and programs and works closely with our project teams to provide oversight, strategic expertise in the planning, coordination, and delivery of all activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. Essential functions of the job include but are not limited to: - Direct, manage and ensure collaboration within a team Project Directors and Project Managers in the planning, execution and governance of projects/portfolios on a global platform
- Provide leadership and oversight on all clinical programs and in some unique cases, manage activities
- Interact with study sponsors as primary point of escalation beyond project management
- Optimize the profitability of the Project Management organization to meet or exceed budget targets
- Assess and manage resource allocations to ensure that established cost, time, and quality goals are met
- Select, train, develop and manage the performance of talent in project leadership positions (Project Directors and Project Managers)
- Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals and deliverables) to assigned project managers
- Identify and escalate impacts to project scope, resources, schedule or budget through standard methods
- Ensure project leadership personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
- Participate with Business Development in opportunity development, proposals and budgeting, bid defense preparation and attendance
- Understand and manage project/program inter-dependencies to achieve program milestones/deliverables
- Conduct evaluations and implement required changes for all projects (including mid-project recovery of at risk projects, re-scoping, postponement, or cancellation)
- Measure and report KPIs and lead continuous improvement
- Recognize, exemplify and adhere to Precision's values that center on our commitment to quality, our people, clients and performance
- Manage workload of supervised staff with continued assessment and adjustment as needed
- Provide on-going feedback, development and coaching of Project Directors and Project Managers including annual performance reviews
Qualifications: Minimum Required: - Bachelor's degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred.
- A minimum 10 years of experience in clinical research, including extensive project management and line management experience or proven competencies for this position
- Working knowledge of GCP/ICH guidelines and the clinical development process
Other Required: - Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project
- Excellent communication and interpersonal skills to effectively interface with others in a team setting
- Excellent organizational skills, attention to detail, and a customer service demeanor
- Ability to travel domestically and internationally including overnight stays
Preferred: - Advanced degree
- Experience in managing complex and global trials
Competencies: |
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