Job Description

At Thermo Fisher Scientific, you'll find rewarding work with a global impact. Join us as we bring our Mission to life, helping customers worldwide create a healthier, cleaner, and safer world. Our teams have the resources to achieve their career goals while advancing science through research, development, and delivering life-changing therapies. With clinical trials in 100+ countries and innovative frameworks for clinical research, we cover laboratory, digital, and decentralized clinical trial services. Your dedication to quality will enhance health outcomes for individuals and communities, both now and in the future.

Our Clinical Operations team at PPD® offers comprehensive support for clinical trials from start to finish, across commercial and government contracts. Together, we assist clients in defining and developing clinical programs, minimizing delays, and conducting high-quality, cost-efficient studies.

As a Clinical Monitoring Specialist, you will coordinate various aspects of clinical monitoring and site management. You'll conduct on-site or remote visits to ensure protocol and regulatory compliance, manage documentation, and adhere to sponsor guidelines and monitoring environments. Acting as a site processes expert, you'll oversee that trials are conducted according to protocol standards, ICH-GCP guidelines, and regulations to safeguard subjects' rights, well-being, and data accuracy. Your role also involves maintaining relationships with investigational sites and ensuring audit readiness.

• Utilize a risk-based monitoring approach to oversee investigator sites and address process failures with corrective actions. Review data accuracy, assess investigational products, and document observations to maintain compliance. Monitor tasks in alignment with approved plans.
• Participate in investigator payment processes and collaborate with the team to resolve issues. Assist in identifying potential investigators and ensuring site compliance with protocols and regulations. Perform trial close-out activities.
• Ensure essential documents are complete and in compliance with regulations through on-site file reviews. Provide progress reports and maintain accurate study systems.
• Facilitate communication between sites, clients, and project teams through various channels. Complete administrative tasks promptly and accurately.
• Contribute to project publications, tools, and process improvement initiatives as needed.

• Bachelor's degree in life sciences
• At least 1-2 years of clinical monitoring experience or equivalent in a relevant field
• Valid driver's license when required
• Equivalent combination of education, training, and related experience considered

• Strong knowledge of medical/therapeutic areas and terminology
• Understanding of ICH GCPs and industry regulations
• Effective communication and interpersonal skills
• Good organizational, time management, and critical thinking skills
• Ability to manage Risk Based Monitoring processes and work independently or within a team
• Proficient in Microsoft Office and digital literacy
• Proficiency in English language and grammar

We pride ourselves on hiring top talent, fostering development, and promoting teamwork. At Thermo Fisher Scientific, you'll benefit from an exceptional learning and development program to help you reach your full potential.

In addition to a competitive salary, we provide a comprehensive benefits package focused on employee well-being. Our flexible work culture encourages a healthy work-life balance while offering a collaborative environment for personal and professional growth.

Our Mission is to empower customers worldwide to create a healthier, cleaner, and safer world. Join us at Thermo Fisher Scientific and be part of a diverse team working towards accelerating research, driving innovation, and supporting those in need.

Thermo Fisher Scientific is an equal opportunity employer that values diversity in experiences, backgrounds, and perspectives.