FSP Local Clinical Trial Manager- Israel
RemoteIsrael
Job Summary
Manage all clinical operational and quality aspects of allocated low-to-moderate complexity studies in compliance with ICH GCP, ensuring timely set up of the Trial Master File and development of clinical tools. Prepare and monitor clinical activity timelines, review monitoring visit reports, and lead team meetings to maintain quality and resource efficiency. Coordinate start-up activities, ethics committee submissions, and site communications regarding protocol and patient participation issues. In smaller regions, conduct Accompanied Field Visits and manage project financials. Work standard Mon-Fri hours with frequent domestic and international travel to site locations.
Required Qualifications
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- Good planning and organizational skills to enable effective prioritization of workload
- Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
- Capable of working effectively in a changing environment with complex/ambiguous situations
- Familiarity with the practices, processes, and requirements of clinical monitoring
- Good judgment and decision making skills
- Effective oral and written communication skills, including English language proficiency
- Capable of evaluating workload against project budget and adjusting resources accordingly
- Sound financial acument and knowledge of budgeting, forecasting and fiscal management
- Strong attention to detail
- Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
- Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
- Must be able to frequently drive to site locations and frequently travels both domestic and international
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