Senior Clinical Trial Manager, CTM

Job not on LinkedIn

🕒 April 9

🇺🇸 United States – Remote

💵 $168k - $188k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🧬 Biotechnology

⚕️ Healthcare Insurance

🔬 Science

Biotechnology • Healthcare Insurance • Science

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• Manage study activities in the successful execution of clinical trials from protocol concept to clinical study report, complying with Good Clinical Practice (GCP) guidelines and international regulations • Manage strategic engagement with key collaborators • Set-up and oversee clinical trial-related trackers such as regulatory documents, trial master file (TMF), startup progress, screening/enrollment, study invoices/payments, project budgets, etc. • Key contributor to IRB/EC and regulatory submissions • Oversee TMF reviews to ensure completeness and inspection readiness • Regularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides) • Identify and mitigate against study risks, escalating as necessary • Direct initiatives to identify and implement best practices and continuous improvement plans in clinical development

🎯 Requirements

• Bachelor’s degree in a scientific field required; advanced scientific degree a plus • 5+ years directly managing clinical trials in Sponsor or CRO setting • In-depth knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements • Experience directing members of clinical operations teams • Experience working in a team across multiple functional areas (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance)

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options