Clinical Team Manager / Sr. (CTM) - Internal Medicine
New
T
Thermo Fisher ScientificPharmaceutical Research
United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 5+ years of relevant experience in clinical research
- Required Skills
- Project ManagementMicrosoft Excel
Requirements
- Bachelor's degree or equivalent relevant formal academic/vocational qualification.
- 5+ years of relevant experience in clinical research, including clinical trial operations, study management, or clinical monitoring.
- Comprehensive understanding of clinical monitoring practices, processes, and requirements.
- In-depth knowledge of ICH/GCP regulations and FDA guidelines.
- Strong leadership, mentoring, and team integration skills.
- Effective planning, organizational, and problem-solving skills for managing complex projects.
- Strong financial acumen, including experience with budgeting, forecasting, and fiscal management.
- Proficiency in computer systems and applications including Microsoft Outlook, Excel, and Word.
- Ability to travel frequently, both domestically and internationally.
Responsibilities
- Manage all clinical operational and quality aspects of assigned studies in compliance with ICH GCP.
- Develop clinical tools such as Monitoring Plans, Monitoring Guidelines, and contribute to Master Action Plans (MAP).
- Collaborate with project managers and clinical teams to maintain timelines, resources, and study quality.
- Monitor study performance using tracking tools, conduct Accompanied Field Visits (AFVs), and oversee project financials.
- Manage clinical resource allocation, task delegation, and study-related communications with sites.
- Oversee Trial Master File organization and ensure regulatory submissions meet compliance standards.
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