Consultant, Clinical Project Manager

• 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