Manager, eTMF and Clinical Trial Management System

🔥 3 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 15%

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Milestone Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2015

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Milestone Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to developing innovative treatments for cardiovascular conditions, specifically focusing on acute episodes of paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation with rapid ventricular rate (AFib-RVR). The company has developed Etripamil, a novel nasal spray calcium channel blocker, designed for at-home treatment, providing an alternative to emergency department or hospital visits. Milestone Pharmaceuticals aims to offer cardiac peace of mind through targeted therapy solutions that address episodic cardiovascular conditions outside of traditional healthcare settings.

📋 Description

• Oversee configuration and validation of CTMS and eTMF platforms within FLEX Databases • Manage day-to-day operations, configuration updates, user provisioning, and user access • Prepare and maintain documentation related to TMF/CTMS processes, procedures, and metrics • Perform risk-based quality reviews of trial documents • Ensure compliance with SOPs and ICH-GCP guidelines • Maintain continuous inspection readiness • Support regulatory inspections and audits by providing requested documents and information • Partner with clinical operations, IT, and QA teams to resolve system issues and support user adoption • Coordinate with external vendors and CROs to track milestones, metrics, and document reconciliation • Generate TMF/CTMS status reports for management review and project team meetings • Act as subject matter expert on TMF/CTMS management • Develop training materials, SOPs, and dashboards to report study metrics to leadership

🎯 Requirements

• Bachelor's degree or equivalent • Minimum of 2 years’ experience with FLEX Databases systems, including CTMS and eTMF management • 6+ years in clinical research • Experience managing the implementation and configuration of eTMF and CTMS modules within FLEX Databases system • Lead or key contributor to validation of CTMS and eTMF modules within FLEX Databases system • Preferred experience with a pharma sponsor or CRO • Thorough understanding of GCP and ICH regulations and regulatory compliance • Highly detail oriented with very strong organizational skills • Demonstrated ability to identify and resolve issues and effectively manage timelines

🏖️ Benefits

• Competitive Health, Dental, and Vision Insurance • Flexible Spending Account • Orthodontia • Short and Long-term disability • Group-Term Life and AD&D • 401k w/ company match • Paid Time Off • Employee Stock Purchase Plan • Competitive compensation • Entrepreneurial environment • Chance for an impactful career

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