Site Monitoring Lead​/Clinical Operations Leader - FSP - Remote

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.

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.

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.

• 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 escalation 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.

• Strong expertise in site monitoring,…