
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.
🔥 16 hours ago
🗣️🇫🇷 French Required
🗣️🇳🇱 Dutch Required
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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.
• Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking and problem-solving to identify site process failures and corrective/preventive actions • Ensure data accuracy through source document review, source data verification and case report form review during on-site and remote monitoring • Assess investigational product through physical inventory and records review • Document observations in reports and letters according to timelines and approved business writing standards • Escalate deficiencies and issues to clinical management and follow them through resolution • Maintain contact with investigative sites between monitoring visits to confirm protocol compliance, issue resolution and timely data recording • Participate in investigator payment processes and findings resolution • Participate in investigator meetings and identify potential investigators with the client company • Initiate clinical trial sites according to procedures, protocol, regulatory and ICH GCP obligations • Perform trial close-out and retrieval of trial materials • Ensure essential documents are complete and in place and conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems according to agreed conventions, including Clinical Trial Management Systems • Assist with project publications and tools and share ideas with project team members • Contribute to project work and process improvement initiatives
• University degree in a science related field • Understanding of ICH-GCP, EU and FDA requirements • Fluency in English, French and Dutch • Valid driver's license • Proven clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge of ICH GCPs, applicable regulations and procedural documents • Critical thinking, root cause analysis and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills • Customer focus, listening skills and attention to detail • Good organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work in a team or independently • Solid knowledge of Microsoft Office and ability to learn appropriate software • CRA experience from all study phases from start to close-out
• Competitive salary • Extensive benefits package focused on employee health and well-being • Flexible working culture • Work-life balance • Collaborative environment • Opportunities to share expertise and have fun with colleagues
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