Consultant, Clinical Project Manager
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- Operationally manage international Phase I-IV clinical trials
- Manage real-world evidence (RWE) projects from set-up through closeout
- Lead local and central teams, including Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), and country project managers
- Manage international Contract Research Organizations (CROs)
- Maintain ongoing coordination with global Medical Affairs, Data Management, and Biostatistics teams
- Ensure compliance with Good Clinical Practice (GCP), ICH regulations, and local and international regulatory requirements
- Manage study timelines and budgets
- Monitor performance and quality indicators
- Collaborate with clients in the pharmaceutical and biotechnology sectors
Requirements
- Doctor of Pharmacy (PharmD), PhD, or Master's degree in a scientific discipline
- Specialization in clinical research preferred
- At least 3-5 years of experience in clinical project management
- Proven experience managing international, multi-country studies
- Fluent or bilingual English required for leading meetings and preparing documentation on a daily basis
- Excellent organizational, attention-to-detail, and forward-planning skills
- Strong interpersonal skills to succeed in a matrix management environment
- Knowledge of and compliance with Good Clinical Practice (GCP)
- Knowledge of ICH regulations and FDA and EMA regulatory requirements
Core Competencies
Demonstrates expertise in managing international clinical trials and real-world evidence projects, ensuring compliance with Good Clinical Practice (GCP) and ICH regulations. Proven ability to lead cross-functional teams and manage study timelines and budgets effectively.
Highest-signal resume keywords
- Clinical Project Management
- Good Clinical Practice (GCP)
- ICH Regulations
- International Multi-Country Studies
- Fluent English
ATS Optimization Keywords
Hard Skills
- Clinical Trial Management
- Real-World Evidence (RWE) Management
- Study Timeline Management
- Budget Management
- Performance Monitoring
Soft Skills
- Organizational Skills
- Attention to Detail
- Interpersonal Skills
- Forward Planning
Industry Keywords
- Pharmaceutical Sector
- Biotechnology Sector
- FDA Regulatory Requirements
- EMA Regulatory Requirements
Tools & Technologies
- Clinical Research Organizations (CROs)
- Data Management Systems
- Biostatistics Tools
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