Senior Clinical Research Project, Trial Manager

Job not on LinkedIn

🔥 4 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 13%

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Saratoga Ascend

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1985

🏥 Healthcare

🎯 Recruiter

🏛️ Government

Healthcare • Recruitment • Government

Saratoga Ascend is a federal- and state-focused healthcare workforce and solutions firm that connects cleared, credentialed healthcare professionals with government, military, and civilian healthcare facilities across the U. S. The company provides clinical and non-clinical staffing, clinical lab and scientific staffing, call center services, federal healthcare consulting, IT solutions, program and administrative support, and SLED (state, local, education) services. With a stated four-decade legacy, nationwide coverage, rapid-fill capabilities, strict credentialing/compliance processes, and operation under federal contract vehicles, Saratoga Ascend positions itself as a government-focused healthcare staffing and program management partner.

📋 Description

• Oversee multi-site or complex clinical trials from start-up through close-out • Manage task-order or contract deliverables, schedules, budgets and risks • Coordinate clinical operations, monitoring, data management, regulatory and quality functions • Provide quality assurance oversight and track corrective actions • Support staffing and transition planning • Lead multidisciplinary teams and coordinate with Government clinical investigators, regulatory staff and program officials • Provide stakeholder communication and Government reporting

🎯 Requirements

• Bachelor's degree in life sciences, nursing, public health or a related field required • Minimum of 8 years of clinical research experience • At least 5 years managing NIH- or FDA-regulated studies and leading multidisciplinary teams • Demonstrated oversight of multi-site or complex clinical trials from start-up through close-out • Experience managing task-order or contract deliverables, schedules, budgets and risks • Proven ability to coordinate clinical operations, monitoring, data management, regulatory and quality functions • Experience with quality assurance oversight, corrective action tracking, and staffing and transition planning • Strong leadership, stakeholder communication and Government reporting skills • Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312 and 812 (as applicable), 45 CFR Part 46, and HIPAA • Current human subjects protections and GCP training (e.g., CITI or equivalent) • Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials • Master's degree or PMP/CCRP/ACRP-CP certification preferred • Experience with gene therapy or rare disease studies is advantageous

🏖️ Benefits

• Competitive rate • Benefit options

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