Katalyst Healthcares & Life Sciences
Clinical Trial Manager
Katalyst Healthcares & Life Sciences, San Diego, California, United States, 92189
Responsibilities:
We are seeking a highly motivated and qualified individual to join our Clinical Department as a Clinical Trial Manager (CTM) and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The CMT will support ongoing RNA-based drug discovery projects in several therapeutic areas. The Clinical Trial Manager (CTM) is responsible for supporting the effective planning and conduct of one or more ADARx Pharmaceuticals clinical trials in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and applicable regulatory. Requirements:
BS/MS in life and health sciences (biology, pharmacology, pharmaceutical sciences or equivalent). 5+ years of combined managing/monitoring Phase 1, 2, or 3 clinical trials. Ability to work across global time zones (including EU, APAC). Experience in performing clinical site monitoring visits, including remote visits. Experience in CRO/Vendor management (domestic/international) monitoring of budget scope. Comprehensive knowledge of ICH, GCP, IRB/IEC, and local regulatory authority requirements. Proficiency working with Microsoft Office Suite Products, EDC, IRT. Ability to travel domestically and internationally if necessary.
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We are seeking a highly motivated and qualified individual to join our Clinical Department as a Clinical Trial Manager (CTM) and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The CMT will support ongoing RNA-based drug discovery projects in several therapeutic areas. The Clinical Trial Manager (CTM) is responsible for supporting the effective planning and conduct of one or more ADARx Pharmaceuticals clinical trials in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and applicable regulatory. Requirements:
BS/MS in life and health sciences (biology, pharmacology, pharmaceutical sciences or equivalent). 5+ years of combined managing/monitoring Phase 1, 2, or 3 clinical trials. Ability to work across global time zones (including EU, APAC). Experience in performing clinical site monitoring visits, including remote visits. Experience in CRO/Vendor management (domestic/international) monitoring of budget scope. Comprehensive knowledge of ICH, GCP, IRB/IEC, and local regulatory authority requirements. Proficiency working with Microsoft Office Suite Products, EDC, IRT. Ability to travel domestically and internationally if necessary.
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