Senior Clinical Trial Manager, Internal Medicine
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 ExcelRisk Management
Requirements
- Have a bachelor's degree or equivalent and a relevant formal academic or vocational qualification.
- Have experience comparable to 8+ years.
- Bring experience in at least one of the stated therapeutic indications, including nephrology, dermatology, cardiovascular, gastrointestinal, liver, immunology, rare disease, diabetes, obesity, dyslipidemia, women's health, rheumatology, or endocrinology.
- Demonstrate leadership skills, including mentoring, training, motivating, and integrating teams.
- Have strong planning and organizational skills for prioritizing individual and team workloads.
- Understand clinical monitoring practices, processes, and requirements.
- Have knowledge of change management, judgment, decision-making, escalation, and risk management.
- Have financial acumen and knowledge of budgeting, forecasting, and fiscal management.
- Understand relevant regulations, including ICH/GCP and FDA guidelines.
- Have effective oral and written communication skills, including English language proficiency.
- Be proficient with computerized applications such as Outlook, Excel, and Word.
Responsibilities
- Manage clinical operational and quality aspects of allocated moderate- to high-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, quality, and archiving of Trial Master File documents and study materials.
- Coordinate with project managers and clinical teams to prepare for client meetings and maintain project timelines, resources, and quality.
- Monitor clinical activity timelines and metrics, review study tracking tools and monitoring visit reports, and implement recovery actions.
- Manage CRF collection and query resolution, and communicate with study sites about protocol and study-related issues.
- Coordinate study start-up activities and regulatory submissions, and follow up on ethics committee questions.
- Provide input to clinical activity forecasts and manage clinical resource assignment and delegation.
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