Parexel
Site and Monitoring Health Lead
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When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel is a leading global clinical development partner delivering insight-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.
About the Role
We are seeking an experienced Site and Monitoring Health Lead to join our team in a remote capacity. As a Site and Monitoring Health Lead, you will play a critical role in advancing clinical research by safeguarding the quality of clinical trial execution at investigator sites and ensuring effective sponsor oversight of CRO monitoring activities.
You will apply extensive knowledge of ICH-GCP, global regulatory requirements, and clinical monitoring practices to support inspection readiness, strengthen quality oversight, and help drive successful study delivery. Working closely with cross-functional teams, investigators, site personnel, and CRO partners, you will contribute to the effective execution of clinical trials that bring innovative therapies to patients.
This is a site-facing position that reports to the FSP Manager, with work directed by the client Associate Director (or above), Site and Monitoring Health Team.
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Key Responsibilities
- Lead oversight of CRO monitoring effectiveness through site risk analyses, site contacts, monitoring visit report reviews, sponsor oversight visits, system and data spot checks, aggregate data reviews, and periodic quality assessments
- Complete Sponsor Oversight Visit reports with a high standard of quality and within established timelines
- Apply a risk-based approach to review critical-to-quality factors at both study and site level while maintaining an inspection-ready mindset
- Develop Study Specific Oversight Plans (SSOPs) for assigned trials and execute oversight activities in accordance with approved plans
- Identify, investigate, and address risks or quality concerns impacting site performance and clinical trial delivery using root cause analysis and risk mitigation strategies
- Support inspection preparation activities and contribute to audit and regulatory readiness across assigned studies
- Build and maintain collaborative relationships with investigators, site staff, CRO partners, and internal cross-functional teams
- Support research sites, particularly those with less clinical trial experience, to help ensure successful study engagement and participant recruitment
- Partner with Clinical Risk and Analytics teams to understand Risk Management Plans, assess site-level risks, and identify emerging trends
- Lead oversight and trend review meetings with study teams and CRO partners to discuss risks, issues, quality signals, and recommended actions
- Implement client Site and Monitoring Health strategies in alignment with ICH-GCP requirements and applicable regulations
- Maintain current knowledge of global and local regulatory requirements relevant to clinical trial oversight activities
Candidate Profile
You’ll thrive in this role if you bring:
- Strengths in risk-based quality oversight, clinical monitoring, and stakeholder relationship management
- Experience working in clinical research and multinational clinical trial environments
- The ability to collaborate effectively with investigators, CROs, site personnel, and cross-functional study teams
- A patient-focused mindset and strong attention to quality, compliance, and operational excellence
- Comfort working with monitoring systems, study oversight processes, risk management methodologies, and Microsoft Office applications
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Required Qualifications
- Bachelor’s Degree required
- Significant direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies
- Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes
- Experience supporting monitoring oversight activities, risk-based quality management, and clinical study execution
- Strong communication, organizational, analytical, and problem-solving skills
- Proficiency with Microsoft Office Suite, including Excel, Word, and PowerPoint
- Proficiency in written and spoken English
- Ability to travel at times up to 50%, including local, regional, and international travel as required
Preferred Qualifications
- Clinical or advanced degree preferred, including Registered Nurse (RN), Master of Public Health (MPH), Master of Science (MS), Master of Arts (MA), Master of Business Administration (MBA), or Doctor of Pharmacy (PharmD)
- Lead CRA or management experience
- Experience across Phase I to Phase III clinical studies
- Experience in both prevalent and rare disease clinical research
- Previous audit and regulatory inspection experience
- Proficiency in local language, where applicable
Benefits and Compensation
- Health, Vision & Dental Insurance
- Vacation/Holiday/Sick Time
- Flexible benefit portal
- Car or car allowance (only applicable roles)
If this job doesn’t sound like the next step in your career, but perhaps you know of someone who’d be a perfect fit, send them the link to apply!
We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.
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