Clinical Project Manager
Job Description: Daily Duties (Co Monitor) • Manage all aspects of global clinical studies (including in-house study team management) to ensure delivery of milestones with regard to clinical studies: completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. • Provide leadership and guidance, global clinical trial management expertise and direction to in-house study team to ensure process consistency and knowledge sharing. • Manage and coordinate activities of Contract Research Organizations and other 3rd party vendors. • Analyze/report safety issues, patient care issues, and study design and/or study conduct issues. • Develop/direct clinical monitoring plans, study management plans and direct study monitoring priorities. Qualifications • Infectious Disease, ICU/critical care experience would be helpful but not required • Bachelor's degree required preferably in a scientific discipline. • Nine or more years experience in clinical development (Sponsor side) and the management of clinical trials; five years of global trial experience; • Excellent Vendor Management / CRO management skills. • Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essential. • Demonstrated proficiency in the implementation, monitoring and management of clinical trials. • Clear and concise verbal and written communication skills. • Strong organizational skills, with an exceptional attention to detail.
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