Site and Monitoring Health Lead

Roles & Responsibilities
• Provide oversight of CRO monitoring effectiveness to safeguard quality of clinical trial execution at investigator sites
• Conduct sponsor oversight activities including site risk analysis, data reviews, monitoring visit report reviews, spot checks, and oversight visits
• Prepare and complete Sponsor Oversight Visit reports accurately and within defined timelines
• Apply a risk-based approach to review critical-to-quality items at site and study level ensuring inspection readiness
• Develop and execute Study Specific Oversight Plans (SSOPs) aligned with risk management plans
• Perform root cause analysis on identified issues and recommend corrective and preventive actions
• Support regulatory inspections and audit preparation activities
• Build and maintain collaborative relationships with investigators and site staff within assigned region
• Support less-experienced sites to improve engagement, quality, and patient recruitment outcomes
• Identify potential investigator sites for new clinical studies
• Collaborate closely with Clinical Risk and Analytics teams to assess site-level risks and trends
• Lead oversight and trend meetings with study teams and CRO partners
• Ensure alignment with ICH-GCP and global/local regulatory requirements
• Maintain compliance with Parexel training, documentation, time reporting, and process requirements

Qualification
• Bachelor’s degree required
• Clinical or advanced degree preferred (RN, MPH, MS, MA, MBA, PharmD, or equivalent)

Experience
• Significant hands-on clinical monitoring experience in CRO or pharmaceutical environment
• Experience across multiple phases of clinical research (Phase I–III)
• Lead CRA or monitoring management experience preferred
• Experience in multinational trials and rare disease studies preferred
• Prior audit and regulatory inspection experience desirable

Skills
• Strong understanding of ICH-GCP and global regulatory requirements
• Excellent analytical, problem-solving, and risk assessment skills
• Ability to think innovatively and implement alternative solutions
• Strong stakeholder management and site relationship-building skills
• Effective verbal, written, and presentation communication skills
• Strong organisational skills with ability to manage competing priorities
• Willingness to travel up to 50% including regional and international travel
• Proficiency in MS Office (Excel, Word, PowerPoint) and ability to learn new systems
• Fluency in English required; additional languages preferred

About the Company
Parexel is a leading global clinical research organization providing end-to-end drug development services to the biopharmaceutical industry. With deep expertise across therapeutic areas and study phases, Parexel partners with sponsors worldwide to accelerate clinical development while maintaining the highest standards of quality, compliance, and patient safety.