
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.
🔥 0 minutes ago
🗣️🇵🇱 Polish 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.
• Perform and coordinate clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor procedures • Act as a site processes specialist to ensure compliance with protocols, ICH-GCP, 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 • Assess investigational products through inventory and records review • Document observations in reports and letters • Escalate deficiencies and follow issues through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payments and investigator meetings • Identify potential investigators and initiate clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete 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 sites, clients and internal project teams • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Contribute to project publications, tools and process-improvement initiatives
• Bachelor's degree in a life sciences related field • At least 1 year of clinical monitoring experience in a clinical environment, including clinical trials, medical terminology, medical research, clinical research or health care • Experience in a health sciences field with formal training in medical terminology and anatomy may be considered • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Basic medical/therapeutic area knowledge and understanding of medical terminology • Ability to attain and maintain working knowledge of ICH GCPs, applicable regulations and procedural documents • Good oral and written communication skills • Good interpersonal skills • Customer focus, listening skills and attention to detail • Good organizational and time management skills • Flexibility and adaptability • Critical thinking, root cause analysis and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Ability to work independently and in a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English and Polish language and grammar skills • Travel requirement higher than 75%
• Competitive salary • Award-winning learning and development programme • Flexible working culture • Work-life balance • Collaborative environment • Opportunities to share expertise and learn from colleagues • Health and well-being benefits package
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