- Develop partnership strategies for clinical trials and programs
- Provide oversight and strategic expertise in planning, coordinating, and delivering designated clinical study projects
- Direct, manage, and ensure collaboration among Project Directors and Project Managers in global project and portfolio planning, execution, and governance
- Provide leadership and oversight on clinical programs
- Serve as the primary escalation point for study sponsors beyond project management
- Optimize Project Management organization profitability against budget targets
- Assess and manage resource allocations to meet cost, time, and quality goals
- Select, train, develop, and manage Project Directors and Project Managers
- Provide technical support and guidance on scope, risks, resources, goals, and deliverables
- Identify and escalate impacts to project scope, resources, schedule, or budget
- Ensure compliance with quality standards, SOPs, project plans, and regulatory requirements
- Participate in business development, proposals, budgeting, bid defense preparation, and attendance
- Manage project and program interdependencies to achieve milestones and deliverables
- Evaluate projects and implement changes, including recovery of at-risk projects, re-scoping, postponement, or cancellation
- Measure and report KPIs and lead continuous improvement
- Manage supervised staff workload and adjust as needed
- Provide ongoing feedback, development, coaching, and annual performance reviews
Requirements
- Bachelor’s degree or equivalent combination of education/experience in science or health-related field
- Minimum 10 years of experience in clinical research, including extensive project management and line management experience, or proven competencies for the position
- Working knowledge of GCP/ICH guidelines and the clinical development process
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and Microsoft Project
- Excellent communication and interpersonal skills for effective teamwork
- Excellent organizational skills, attention to detail, and customer service demeanor
- Ability to travel domestically and internationally, including overnight stays
- Working knowledge of project management techniques and tools
- Direct work experience in a global, cross-functional project management environment
- Proven people management experience
- Proven strategic planning, risk management, and change management experience
- Strong analytical skills and business acumen
- Executive presence and ability to deliver complex presentations to senior management
- Demonstrated leadership track record and effective interpersonal skills
- Proficient in project management software
- In-depth proven experience in pharmaceutical and/or device research
Core Competencies
Demonstrates extensive experience in clinical research project management, including strategic planning, risk management, and compliance with GCP/ICH guidelines. Proven ability to lead cross-functional teams, optimize project profitability, and deliver complex presentations to senior management.
Highest-signal resume keywords
- Clinical Research Management
- Project Management Techniques
- GCP/ICH Guidelines Knowledge
- Strategic Planning Experience
- People Management Experience
ATS Optimization Keywords
Hard Skills
- Project Management
- Clinical Development Process
- Risk Management
- Change Management
- KPI Measurement
- Budgeting
- Resource Allocation
- Continuous Improvement
- Analytical Skills
- Pharmaceutical Research
Soft Skills
- Excellent Communication
- Interpersonal Skills
- Organizational Skills
- Attention to Detail
- Customer Service Demeanor
Industry Keywords
- Clinical Trials
- Global Project Management
- Cross-Functional Collaboration
- Study Sponsors
- Regulatory Compliance
Tools & Technologies
- Microsoft Office Products
- Microsoft Project
- Project Management Software