Sr. Clinical Project Manager

Job Summary

The Senior Clinical Project Manager is responsible for leading the planning execution and delivery of global MedTech clinical studies supporting the development and commercialization of medical devices. This individual serves as the primary point of contact for sponsors and cross-functional teams ensuring studies are delivered on time within budget and in compliance with applicable regulatory and quality requirements.

The Senior Clinical Project Manager provides strategic leadership across multi-country clinical programs driving operational excellence customer satisfaction and successful study outcomes.

Job Responsibilities

• Lead the planning execution and delivery of global and multi-country MedTech clinical studies.

• Serve as the primary project contact for sponsors and maintain strong client relationships throughout the study lifecycle.

• Develop and manage study timelines budgets forecasts risk management plans and project deliverables.

• Lead cross-functional project teams to ensure milestones are achieved and study objectives are met.

• Monitor study progress and proactively identify escalate and resolve project risks and issues.

• Ensure compliance with ICH-GCP ISO 14155 applicable regulatory requirements SOPs and quality standards.

• Collaborate with Clinical Operations Data Management Biostatistics Regulatory Affairs Safety and other functional groups to support successful study execution.

• Manage study finances including forecasting scope management change orders and overall project profitability.

• Support bid defenses and business development activities for new opportunities.

• Drive continuous process improvement and share lessons learned and best practices across project teams.

• Mentor and support the development of junior project management and clinical operations staff.

• Provide regular project updates and strategic recommendations to sponsors and internal stakeholders.

Job Qualifications

Education

• Bachelors degree in Life Sciences Nursing Biomedical Engineering Public Health Healthcare or a related scientific discipline required.

Experience

• Minimum of 7 years of clinical research experience including at least 4 years of clinical project management experience.

• Experience managing clinical studies within the MedTech medical device diagnostics CRO biotechnology pharmaceutical or healthcare industries.

• Demonstrated experience leading global and multi-country clinical studies across North America Europe Asia-Pacific and other regions.

• Experience managing cross-functional project teams and complex stakeholder relationships.

• Experience supporting studies intended for regulatory submissions product development and post-market evidence generation preferred.

Knowledge Skills & Abilities

• Strong knowledge of clinical trial management and applicable regulations including ICH-GCP ISO 14155 FDA and global regulatory requirements.

• Proven ability to lead global cross-functional teams in a matrix environment.

• Excellent client relationship management communication presentation and negotiation skills.

• Strong project planning organizational and problem-solving abilities.

• Demonstrated experience managing project budgets contracts forecasting and financial performance.

• Ability to manage multiple priorities and deliver results in a fast-paced environment.

• Strong attention to detail and commitment to quality.

• Advanced proficiency with Microsoft Office and clinical trial management systems.

• Ability to effectively collaborate across global teams and cultures.

• Demonstrated commitment to customer service operational excellence and continuous improvement.