Associate Clinical Operations Leader

• Coordinate and direct clinical project team members on small to midsize studies
• Provide productivity targets, performance feedback, and input to study-specific training
• Manage study start-up activities, including project plans, site selection strategy, monitoring plans, and patient recruitment and retention plans
• Monitor study timelines, patient recruitment, patient retention, and data cleaning
• Address escalated site issues, identify potential problems early, and support contingency planning
• Communicate with internal and external customers, sponsors, investigational sites, and third-party vendors
• Evaluate resourcing needs and monitor resource use across the project life cycle
• Prepare for and participate in audits and inspections
• Support maintenance and quality checks of central files
• Ensure compliance with ICH-GCP, local regulatory requirements, Parexel SOPs, work instructions, and operational guidelines
• Collaborate on database lock, project close-out, and archiving activities
• Support process improvement initiatives and contribute lessons learned at study close-out

• Degree in a life science or a nursing qualification, or relevant clinical or clinical management experience
• Substantial relevant work experience in clinical research operations, such as Clinical Research Associate (CRA) experience or equivalent
• Knowledge of International Council for Harmonisation (ICH) Good Clinical Practice (GCP), regulatory requirements, and clinical trial processes across the full project life cycle
• Strong command of written and spoken English, with local language proficiency as required
• Strong communication, organization, and problem-solving skills
• Ability to manage multiple tasks and prioritize workload with attention to detail
• Proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook) and WebEx
• Ability to become proficient with Parexel systems
• Coordinating experience, preferably gained in a Senior CRA or Senior CMA position
• On-site monitoring experience
• Local language proficiency for assigned countries
• Ability to travel as required

• Flexible work arrangements
• Growth opportunities
• Continuous learning opportunities
• Career path exploration and skill expansion
• Diverse teams
• Ability to travel as required