Site Monitoring Lead/Clinical Operations Leader - FSP - Remote

Job description

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. About Parexel Parexel is a leading global clinical development partner delivering insights 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 Monitoring Lead (SML) to join our Functional Service Provider Clinical Operations team supporting a global sponsor. As a key member of the Clinical Development & Operations team, the Site Monitoring Lead plays a critical role in the successful planning, oversight, and delivery of global clinical trials. This position is accountable for trial level site monitoring strategy, risk assessment, operational oversight, and collaboration with CRO partners to ensure high quality execution of clinical studies. The Site Monitoring Lead works closely with global clinical trial teams to drive performance, support inspection readiness, protect study participants, and ensure compliance with study protocols, ICH GCP, sponsor requirements, and applicable regulations. Key Responsibilities Lead the development and execution of trial level site monitoring and oversight strategies, including monitoring risk assessments and site monitoring plans. Provide oversight of CRO delivered site management and monitoring activities to ensure quality, compliance, and timely study execution. Conduct trial level trend analysis, signal detection, risk identification, and issue management to support proactive decision making. Drive a risk based site monitoring approach and ensure monitoring activities align with study objectives and quality requirements. Collaborate with Clinical Trial Managers, Clinical Research Associates, and cross functional stakeholders to support study delivery against milestones and key performance indicators. Participate in the development and maintenance of trial level documents, amendments, training materials, and monitoring related procedures. Lead and contribute to trial oversight meetings, investigator meetings, and cross functional study discussions at global, regional, and local levels. Conduct site and monitoring oversight activities, implement follow up actions, and escalate issues when required. Serve as a subject matter expert on site management and monitoring, providing guidance and training to study teams. Support trial close out activities, including coordination of clinical data delivery and contribution to quality sections of clinical study reports. Facilitate timely responses to monitoring related questions from internal stakeholders, CRO partners, regulatory authorities, and ethics committees. Ensure inspection readiness and ongoing compliance with sponsor obligations, ICH GCP guidelines, SOPs, and regulatory requirements. Candidate Profile You’ll thrive in this role if you bring: Strong expertise in site monitoring, clinical trial oversight, and risk based quality management Experience working within global clinical development and regulated research environments The ability to influence and collaborate effectively across complex cross functional and matrix teams A patient focused mindset with a commitment to quality, compliance, and operational excellence Excellent communication, leadership, and stakeholder management skills The ability to identify risks, solve complex challenges, and drive successful study outcomes Strong organizational skills and attention to detail within fast paced global clinical programs Required Qualifications University degree (Bachelor's or equivalent) in life sciences or a related field, or several years of equivalent professional education combined with significant experience in site monitoring and site management Several years of experience in site monitoring, site management, clinical trial operations, or a related clinical research field Demonstrated scientific and operational expertise across all aspects of clinical trial planning, site monitoring, and execution Strong knowledge of ICH GCP, regulatory requirements, sponsor oversight responsibilities, and clinical trial processes Proven ability to oversee complex clinical trials involving multiple sites, countries, vendors, and stakeholders Strong communication, organizational, training, and problem solving skills Fluent English language skills, both written and spoken. Preferred Qualifications Advanced education in life sciences or a related discipline Experience supporting global clinical trials across multiple regions and countries Experience working within CRO, sponsor, or Functional Service Provider delivery models Demonstrated expertise in risk based monitoring strategies and clinical quality oversight Experience facilitating trial oversight meetings, investigator meetings, and cross functional study governance activities. Benefits and Compensation Health, Vision & Dental Insurance Vacation/Holiday/Sick Time Flexible benefit portal 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