Clinical Research Project Manager

Overview

• Manage clinical research projects, ensuring compliance with regulatory standards and delivering high-quality outcomes.
• Collaborate with cross-functional teams to design and execute robust study protocols.
• Lead data collection efforts, ensuring accuracy and alignment with study objectives.
• Provide leadership in project planning, execution, and reporting for clinical studies.
• Ensure adherence to global regulatory requirements, including EU MDR and ISO 14155.
• Collaborate with vendors and sites to facilitate effective study execution.
• Prepare comprehensive study reports and support regulatory submissions.
• Drive project outcomes through strong organizational leadership and risk management.

Key Responsibilities & Duties

• Lead clinical research projects, including retrospective chart reviews and data analyses.
• Develop and implement scientifically robust data collection protocols.
• Ensure quality control through rigorous data monitoring and query resolution.
• Collaborate with cross-functional teams to align study endpoints with objectives.
• Manage external vendors and oversee site qualification and activation.
• Provide timely updates and escalate issues to stakeholders as needed.
• Prepare study reports and support data interpretation and publications.
• Ensure compliance with regulatory standards, including GCP and GDPR.

Job Requirements

• Bachelor’s degree in life sciences, biomedical engineering, or related field.
• Minimum 3 years of experience managing clinical research projects.
• Knowledge of regulatory standards such as ISO 14155 and EU MDR.
• Experience with electronic data capture systems and study design.
• Proven ability to lead cross-functional teams and manage vendors.
• Preferred experience in vascular or cardiovascular clinical studies.
• Familiarity with safety and performance endpoints in vascular studies.
• PMP certification or equivalent is highly desirable.