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.
Local Clinical Trial Manager
🔥 0 minutes ago
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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 clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP • Develop clinical tools and contribute to the Data Quality Plan and Master Action Plan • Ensure timely setup, organization, content, and quality of local and central Trial Master File sections • Participate in the design and development of CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Collaborate with the project manager to prepare and present client meetings, including bid defense and hand-off meetings • Lead clinical team meetings and coordinate teams and departments to maintain timelines, resources, interactions, and quality • Implement and train standardized clinical monitoring processes • Archive study documents and materials on time • Achieve final clinical deliverables by monitoring timelines and metrics, providing project updates, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution • Monitor or co-monitor clinical trials and ensure contractual obligations are met • Conduct Accompanied Field Visits and manage project financials where applicable • Communicate with study sites about protocol, patient participation, case report forms, and related study issues • Coordinate study start-up activities and ensure timely ethics committee and regulatory submissions • Ensure essential document quality meets Regulatory Compliance Review expectations and follow up on ethics committee questions • Provide input into clinical activity forecasts • Manage clinical resources, delegate clinical responsibilities, and identify additional resource requirements
🎯 Requirements
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of comparable experience • Equivalency through a combination of appropriate education, training, and directly related experience may be considered • Leadership, mentoring, training, and team motivation skills • Planning and organizational skills for workload prioritization • Interpersonal and problem-solving skills in a multicultural matrix organization • Ability to work effectively in changing environments with complex or ambiguous situations • Familiarity with clinical monitoring practices, processes, and requirements • Judgment and decision-making skills • Effective oral and written communication skills, including English language proficiency • Ability to evaluate workload against project budgets and adjust resources • Financial acumen and knowledge of budgeting, forecasting, and fiscal management • Strong attention to detail • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • Computer skills using Outlook, Excel, Word, and similar automated systems • Frequent domestic and international travel and driving to site locations
🏖️ Benefits
• Collaboration and development as part of the everyday experience • Reasonable accommodation for individuals with disabilities during application, interview, and job functions • Equal employment opportunity
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