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
Skills Required
- Bachelor’s degree or equivalent in life sciences or a related field, or equivalent professional education combined with significant site monitoring and site management experience
- Several years of experience in site monitoring, site management, clinical trial operations, or a related clinical research field
- Scientific and operational expertise across clinical trial planning, site monitoring, and execution
- Strong knowledge of ICH GCP, regulatory requirements, sponsor oversight responsibilities, and clinical trial processes
- Experience overseeing complex clinical trials involving multiple sites, countries, vendors, and stakeholders
- Strong communication, organizational, training, and problem-solving skills
- Fluent written and spoken English
- Advanced education in life sciences or a related discipline
- Experience supporting global clinical trials across multiple regions and countries
- Experience within CRO, sponsor, or Functional Service Provider delivery models
- Expertise in risk-based monitoring strategies and clinical quality oversight
- Experience facilitating trial oversight meetings, investigator meetings, and cross-functional study governance activities
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
