Clinical Team Manager – Neuro
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Job Description
Clinical Trial Manager leading low- to moderate-complexity neuro clinical studies for Thermo Fisher Scientific. Managing trial deliverables, monitoring, teams, regulatory submissions, and study resources.
Responsibilities:
- 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 Trial Master File sections
- Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
- Collaborate with project managers to prepare and present at client meetings
- Lead clinical teams and meetings to maintain timelines, resources, interactions, and quality
- Implement and train teams on standardized clinical monitoring processes
- Ensure timely archiving of study documents and materials
- Monitor clinical activity timelines and metrics, provide project status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution
- Continuously monitor or co-monitor clinical trials and ensure contractual obligations are met
- Conduct Accompanied Field Visits and manage project financials in smaller regions when applicable
- Communicate with study sites regarding protocol, patient participation, case report forms, and related issues
- Coordinate study start-up activities and ethics committee and regulatory submissions when applicable
- Review and follow up on ethics committee questions
- Provide input into clinical activity forecasts
- Manage clinical resources, delegate responsibilities, and identify additional resource requirements
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- 5+ years of relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or related clinical research activities
- Transferable experience in healthcare, nursing, medicine, or related disciplines may be considered in combination with clinical trial experience where the candidate demonstrates significant clinical expertise, therapeutic area knowledge, and direct patient care responsibilities
- Experience in end-to-end study management of studies
- Familiarity with clinical monitoring practices, processes, and requirements
- Knowledge of ICH/GCP, FDA guidelines, and relevant regulations
- English language proficiency
- Good computer skills, including Outlook, Excel, and Word
- Knowledge of budgeting, forecasting, and fiscal management
- Ability to evaluate workload against project budget and adjust resources accordingly
- Early Phase and Start-up experience preferred
- Neurology therapeutic experience preferred
Benefits:
- Global team environment
- Collaboration and development opportunities
- Scientific excellence-focused work environment
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