Clinical Trial Manager

Job Summary:We are seeking an experienced and proactive Clinical Trial Manager (CTM) to lead clinical trial activities from study start-up through close-out. The CTM will be responsible for overall clinical operations of assigned studies, including onsite oversight monitoring and functional management of Clinical Research Associates (CRAs). This role ensures quality trial conduct, adherence to timelines and budgets, and compliance with regulatory requirements and company SOPs.Key Responsibilities:Study Management & Site Oversight:Manage day-to-day clinical trial operations including study planning, site selection, initiation, monitoring, and close-out activities.Conduct onsite oversight monitoring visits to evaluate site performance, data quality, protocol compliance, and CRA effectiveness.Oversee resolution of site-level issues and work with investigative sites to drive performance and compliance.CRA Oversight & Team Leadership:Provide operational oversight and functional leadership to CRAs assigned to the study.Review and approve CRA visit reports for quality and completeness.Conduct CRA co-monitoring and accompanied site visits to evaluate monitoring quality and provide mentoring/coaching.Lead CRA training, including study-specific onboarding and continuous education.Monitor CRA compliance with study timelines, issue resolution, and monitoring visit schedules.Project Execution & Quality Oversight:Develop and maintain study plans including the monitoring plan, communication plan, and risk management plan.Track study progress against timelines, milestones, and deliverables.Identify, escalate, and proactively manage clinical risks and issues.Support audit and inspection readiness and responses, ensuring inspection-quality documentation.Cross-Functional Collaboration:Serve as the primary liaison between sites, CRAs, vendors, and internal teams.Collaborate with regulatory, data management, medical monitoring, and quality teams throughout the study lifecycle.Contribute to vendor/CRO management, if applicable.Qualifications:Bachelor's degree in life sciences, nursing, pharmacy, or related field (or equivalent experience).Minimum of 6–8 years of clinical trial experience, including at least 2 years as a Clinical Trial Manager or in a CRA oversight role.Strong knowledge of ICH-GCP, clinical operations, and regulatory requirements.Proven experience in oversight of monitoring activities, CRA management, and site performance.Experience with global studies and/or a variety of therapeutic areas preferred.Ability to travel to clinical sites and team meetings as required (up to XX%).Skills & Competencies:Strong leadership and team management skills.Excellent communication and interpersonal abilities.Strategic thinker with problem-solving capabilities.Highly organized, detail-oriented, and capable of managing multiple priorities.Proficiency with CTMS, eTMF, EDC systems, and MS Office Suite.