kps life · 2 days ago
Sr. Clinical Trial Manager
United States
Full-time
Remote
Senior Level, Lead/Staff
8+ years expKPS Life is dedicated to advancing global Phase II–III clinical programs and is seeking a Senior Clinical Trial Manager. The role involves managing and overseeing global clinical trials, ensuring compliance with regulatory guidelines, and leading cross-functional teams to achieve project deliverables.
Health CareMedicalWellness
Hiring Manager
Brian Jardon
Responsibilities
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
Qualification
Required
8+ years of experience in clinical trial management
strong global trial management expertise
management and oversight of global phase I-IV clinical trials
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
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
effectively managing third-party suppliers to contracted deliverables within quality, cost, and timeline parameters
managing and/or assisting with cross-functional clinical study team members to achieve deliverables with high quality, on time, and within budget
monitoring study metrics to ensure quality and performance standards are met by vendors and assigned program staff
developing and managing detailed project and other trial-related plans and documentation
providing regular study status updates to senior management
managing vendors' adherence to contractual obligations
coaching/mentoring assigned program staff (CRAs, and CTAs)
working collaboratively with Clinical Scientist, Clinical Indication/Development Lead, and clinical study team
proactively identifying potential resource needs to management
participating in the development and review of department SOPs and process improvement initiatives
Preferred
rare disease background
Company
kps life
KPS Life is a functional service solution that improves efficiency, lowers trial costs, and gives the sponsor strategic control.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$3.5M2025-06-11Undisclosed· $3.5M
2021-02-26Debt Financing
2021-01-12Private Equity
Leadership Team
Kevin Duffy
Chief Commercial Officer
Recent News
2023-06-05
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