Clinical Research Associate/ Project Management

About the Role

The role involves supporting the planning, execution, and monitoring of clinical trials, with a particular focus on clinical operations and supply chain coordination.

Key Responsibilities

• Reviewing and implementing study protocols.
• Overseeing site initiation and management.
• Tracking project timelines and milestones.
• Ensuring compliance with regulatory and quality standards.
• Collaborating with cross-functional teams, clinical sites, and vendors to address operational challenges, optimize processes, and maintain accurate documentation.
• Contributing to risk assessment, issue resolution, and continuous improvement of project management practices.

Qualifications

• Demonstrated experience in clinical trials and clinical research, with a strong understanding of study design and execution.
• Knowledge of clinical operations and project management practices, including coordination of trial activities and timelines.
• Ability to interpret and work with study protocols, ensuring adherence to regulatory, quality, and ethical standards.
• Experience collaborating with Clinical Research Associates, investigators, and site personnel to support site performance.
• Strong analytical and research skills, with attention to detail and accuracy in documentation and reporting.
• Excellent communication and interpersonal skills for working with global, cross-functional teams and external partners.
• Proficiency with common clinical trial and project management tools or systems.
• Familiarity with GCP and ICH guidelines.
• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field.
• Advanced degree or relevant certifications are an advantage.