Thermo Fisher Scientific
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.
Senior CTM – Internal Medicine, Dermatology, Cardiovascular, Liver, Nephrology, Immunology, Rare Disease, Diabetes
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Thermo Fisher Scientific
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.
📋 Description
• Manage all clinical and start-up activities, operational and quality aspects of allocated moderate- to high-complexity studies in compliance with ICH GCP • Develop start-up and clinical tools, including Essential Document Checklists, Monitoring Plans, and Monitoring Guidelines • Contribute to the Master Action Plan for clinical-related documents • Ensure timely setup, organization, content, and quality of relevant Trial Master File sections • Participate in designing and developing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Collaborate with the Project Manager to prepare, organize, and present client meetings, including bid defense and hand-off meetings • Collaborate with country start-up, regulatory, clinical, and other departments to meet project deliverables • Communicate regularly with teams and lead team meetings to maintain timelines, resources, interactions, and quality • Implement and train standardized clinical monitoring processes according to corporate policies • Archive documents and study materials in a timely manner • Monitor start-up and clinical timelines and metrics, provide status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Continuously monitor clinical trials to assess performance and meet contractual obligations • Conduct Accompanied Field Visits and be accountable for project financials when required • Communicate with study sites about protocols, patient participation, case report forms, and study-related issues • Coordinate start-up activities and ensure essential document quality meets Regulatory Compliance Review expectations • Ensure timely regulatory submissions and follow up on ethics committee questions • Provide input into forecast estimates for start-up and clinical activities • Manage start-up and clinical resources, delegate responsibilities, and identify additional resource requirements • Support sponsors on all clinical aspects of projects • Work with the Project Manager to ensure training, tracking, and quality systems are in place
🎯 Requirements
• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Equivalent combination of appropriate education, training, and/or directly related experience may be considered • Strong leadership, mentoring, and training skills • Strong planning and organizational skills • Strong interpersonal and problem-solving skills in a multicultural matrix organization • Solid understanding of change management principles • Comprehensive understanding of start-up and clinical monitoring practices, processes, and requirements • Strong judgment, decision-making, escalation, and risk management skills • Effective oral and written communication skills, including English language proficiency • Ability to evaluate workload against project budgets and adjust resources • Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management • Strong attention to detail • In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines • Strong computer skills, including Outlook, Excel, Word, and computerized applications • Ability to independently manage clinical-only studies • Ability to work under pressure while prioritizing and handling multiple projects • Ability to travel independently up to 20% by automobile, airplane, and train • Junior CTMs are not considered
🏖️ Benefits
• Continued career advancement opportunities • Award winning training • Benefits focused on the health and wellbeing of employees • Reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive employment benefits and privileges
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