Sr. Clinical Trial Manager

Remote, USA Full-time
Opportunity Details On Assignment Sr. Clinical Trial Manager Remote, United States Join the KPS Life team dedicated to one of our sponsor partners as a Senior Clinical Trial Manager and play a key role in advancing global Phase II–III clinical programs. You’ll drive start-up, oversee global vendors and CROs, manage data quality, and lead cross-functional execution. We’re seeking CTM leaders with 8+ years of experience and strong global trial management expertise(rare disease background a plus.) East Coast candidates encouraged to apply! The Sr. Clinical Trial Manager will be responsible for the management and oversight of global phase I-IV clinical trials, with a key focus on Ph2b-3, from start up through CSR including, but not limited to, development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, management of third-party vendors for clinical services, management of project timelines and deliverables. Key global trial management support to the Associate Directors (CST Leads), as assigned. The Senior Clinical Trial Manager will be responsible for, but not limited to: • Leading and coordinating the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines • Detailed management and oversight of regional trial activities, as assigned • Effectively manages third-party suppliers to contracted deliverables within quality, cost, and timeline parameters • Effectively manage and/or assist with cross-functional clinical study team members to achieve deliverables with high quality, on time, and within budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning • Monitor study metrics to ensure quality and performance standards are met by vendors and assigned program staff • Develop and manage detailed project and other trial-related plans and documentation and provide regular study status updates to senior management • Manage vendors' adherence to contractual obligations including proactively recognizing changes in scope and collaborating with senior management to ensure timely completion of contractual documents, including change orders • Provide coaching/mentoring to assigned program staff (CRAs, and CTAs) by demonstrating leadership competencies • Work collaboratively with Clinical Scientist, Clinical Indication/Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings • Proactively identify potential resource needs to management • Participate in the development and review of department SOPs and process improvement initiatives #kpslife Apply tot his job
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