
10,000+ employees
Founded 1956
🏥 Healthcare
📦 Logistics
🏭 Manufacturing
Healthcare • Logistics • Manufacturing
Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
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10,000+ employees
Founded 1956
🏥 Healthcare
📦 Logistics
🏭 Manufacturing
Healthcare • Logistics • Manufacturing
Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
• Perform and coordinate clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required documentation and sponsor or monitoring-environment procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking, and problem-solving to identify failures and corrective/preventive actions • Ensure data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring • Assess investigational product inventory and records • Prepare timely monitoring reports and letters; escalate and resolve deficiencies • Maintain contact with investigative sites between monitoring visits • Participate in investigator payments and investigator meetings • Identify potential investigators and initiate clinical trial sites • Perform trial close-out and retrieve trial materials • Review essential documents and conduct on-site file reviews • Track trial status and provide progress updates • Maintain complete and accurate study systems, including Clinical Trial Management Systems • Facilitate communication among investigative sites, the client company, and internal project teams • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Support project publications, tools, process improvement, and other project initiatives
• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Minimal clinical monitoring experience comparable to 2 years in a clinical environment involving clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology and anatomy • Valid driver's license where applicable • Equivalent combination of appropriate education, training, and/or directly related experience may be considered • Basic medical/therapeutic area knowledge and medical terminology • Working knowledge of ICH GCPs, applicable regulations, and procedural documents, or ability to attain and maintain it • Good oral and written communication skills • Good interpersonal, organizational, and time management skills • Critical thinking, root cause analysis, and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Ability to work independently or in a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Willingness and ability to travel frequently, generally 60–80%, including possible overnight stays • Ability to work in environments with potential exposure to biological fluids and infectious organisms, with required personal protective equipment
• Fully remote work arrangement • Full-time employment
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