Senior CTM - Neuroscience
New
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Thermo Fisher ScientificClinical research
Remote, United KingdomFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English language proficiency
- Experience
- Comparable to 8+ years
- Required Skills
- Microsoft Excel
Requirements
- Bachelor's degree or equivalent and a relevant formal academic or vocational qualification.
- Previous experience providing the knowledge and skills to perform the role, comparable to 8+ years.
- Extensive experience in neuroscience indications, including ophthalmology, rare disease, sleep, epilepsy, and/or psychiatry.
- Familiarity with clinical monitoring practices, processes, and requirements.
- Solid understanding of relevant regulations, including ICH/GCP and FDA guidelines.
- Leadership skills, including mentoring, training, motivating, and integrating teams.
- Planning, organizational, interpersonal, and problem-solving skills for prioritizing work in a multicultural matrix organization.
- Ability to work effectively in a changing environment with complex or ambiguous situations.
- Knowledge of project budgets, workload assessment, resource adjustment, budgeting, forecasting, and fiscal management.
- Effective oral and written communication skills, including English language proficiency.
- Computer skills using Outlook, Excel, Word, and other automated systems and computerized applications.
- Frequently travel domestically and internationally and drive to site locations.
Responsibilities
- Manage clinical operational and quality aspects of allocated studies in compliance with ICH GCP.
- Develop clinical tools, including monitoring plans and guidelines, and contribute to the Data Quality Plan and Master Action Plan.
- Set up and maintain relevant local and central Trial Master File sections, and support development of CRFs, consent templates, and other protocol-specific documents.
- Collaborate with project managers and clinical teams to prepare client meetings, coordinate deliverables, and lead team meetings.
- Monitor study timelines, metrics, project status, and contractual obligations; implement recovery actions as needed.
- Review monitoring visit reports and manage CRF collection and query resolution.
- Communicate with study sites about protocol, patient participation, case report forms, and other study issues.
- Coordinate study start-up and ethics committee and regulatory submissions when required; review and follow up on ethics committee questions.
- Manage clinical resources, delegate responsibilities, identify additional resource needs, and contribute to clinical activity forecasts.
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