CTM

Clinical Trial Managaer

Remote (USA)

$70-$90 per hour

Job Description

EPM is partnered with a cutting-edge biotech that is dedicated to pioneering breakthrough therapies for diverse and traditionally unmet medical needs related to liver diseases. Their mission? To revolutionize healthcare and the way that patients are treated across the globe. With a diverse pipeline of various clinical stage assets across a number of therapeutic areas, the potential regarding their drug platform is unlimited. By harnessing the power of data driven drug development, they are able to precisely and efficiently create new treatments that are not only cheaper, but more effective as well.

Key Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or a related field (Master's or advanced degree preferred).
• 5+ years of experience in clinical research, with at least 2 years in a clinical trial management or leadership role.
• In-depth knowledge of ICH-GCP guidelines, FDA regulations, and international clinical trial requirements.
• Phase 3 experience required
• Proven experience managing CROs, vendors, and clinical sites, including oversight of budgets, contracts, and timelines.
• Strong project management skills, including the ability to lead cross-functional teams and manage multiple studies simultaneously.
• Proficiency with clinical trial management systems (CTMS) and electronic Trial Master File (eTMF) platforms.
• Excellent communication, leadership, and problem-solving skills, with the ability to make data-driven decisions and manage risk.

Roles and Responsibilities

• Oversee the planning, execution, and management of clinical trials, ensuring they are conducted in compliance with protocols, GCP, and regulatory requirements.
• Lead cross-functional study teams, including Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs), data managers, and biostatisticians.
• Develop and manage study timelines, budgets, and resources, ensuring milestones are met on schedule and within scope.
• Select, train, and manage clinical trial sites and vendors, including contract research organizations (CROs).
• Monitor trial progress and resolve issues, including protocol deviations, site performance, and data quality concerns.
• Ensure proper documentation and maintenance of the Trial Master File (TMF) and other regulatory documents.
• Prepare and present study updates to internal stakeholders and regulatory bodies, including risk assessments and mitigation strategies.
• Support regulatory submissions and audits, ensuring inspection readiness at all times.