Clinical Trial Manager

Job not on LinkedIn

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $145k - $150k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

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Clinilabs

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2000

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Clinilabs is a global, full-service Contract Research Organization (CRO) specializing in the development of central nervous system (CNS) drugs, devices, and technology. The company provides comprehensive services to pharmaceutical, biotechnology, and medtech organizations, supporting their projects from first-in-human to Phase 3 clinical trials. Clinilabs is dedicated to addressing the significant unmet needs in CNS drug development, focusing on neurological, mental health, and substance use disorders.

📋 Description

• Develop the clinical operational delivery strategy aligned with the protocol, Sponsor objectives, contracted scope, timelines, and budget • Lead Clinical Operations activities from study planning through study completion across countries and regions • Maintain protocol and amendment training curricula for assigned CRAs and ensure retraining after amendments • Translate protocol requirements into executable clinical delivery plans and develop study documentation, including CRFs, monitoring plans, reference manuals, and tracking logs • Serve as the primary clinical contact and resource for CRAs, sites, and customers • Collaborate with the Project Manager and functional leads on monitoring strategy and schedules • Ensure site source documents, CRFs, and/or EDC are accurate, complete, and compliant with GCP, ICH guidelines, and protocol requirements • Identify scope changes, assess impacts, and communicate them to the Project Manager • Identify clinical risks and underperforming or high-risk sites and implement corrective or recovery plans • Participate in Sponsor meetings and present Clinical Operations status, risks, trends, and recommendations • Contribute to site identification, selection, and global recruitment strategies • Ensure sites are operationally ready before initiation and enrollment and monitor site performance using metrics and indicators • Communicate study progress to relevant parties and formulate corrective action plans where needed • Attend Investigator Meetings and other Sponsor or agent meetings as needed • Lead and/or line manage CRAs, Site Managers, and regional/country Clinical Operations resources • Develop operational enrollment strategies, establish recruitment expectations, and evaluate the need for additional sites or countries • Develop, implement, and maintain the Clinical Monitoring Plan • Determine appropriate on-site, remote, centralized, and targeted monitoring activities • Review monitoring compliance, quality, findings, and trends, adapting strategy to emerging risks • Escalate and resolve significant findings • Participate in study-level risk assessment and translate risks into clinical monitoring strategies • Understand critical data, processes, and Critical-to-Quality factors • Participate in Bid Defense Meetings and present Clinical Operations, site management, recruitment, monitoring, and RBM strategies • Perform monitoring responsibilities as required • Perform other clinical research duties as required

🎯 Requirements

• Bachelor's or master's degree in life sciences, nursing, or an equivalent field • 2+ years of clinical trial management experience • Minimum of one year of experience as a clinical monitor • Therapeutic knowledge of CNS trial methodologies and scale management • Good understanding of the overall drug development process, including study initiation procedures, clinical monitoring functions, drug safety and regulatory requirements, and report generation • Proficiency with ICH/GCP guidelines, including E6(R2) and E6(R3), Risk-Based Monitoring, and RBQM principles • Excellent verbal and written communication, organizational, time-management, customer service, and interpersonal skills • Strong global Clinical Operations leadership and end-to-end ownership • Ability to partner with the Project Manager while maintaining clear Clinical Operations accountability • Ability to lead geographically dispersed teams and influence without direct line-management authority • Ability to work independently • Certified Clinical Research Associate (CCRA), as applicable per regulations • Experience in clinical risk management and cross-functional study-delivery leadership • Experience participating in proposal development and presenting at bid defense meetings • Experience with CTMS and eTMF systems • Flexibility to travel internationally as needed

🏖️ Benefits

• Global/regional travel on an as-needed basis • Professional development support • Ongoing mentorship and performance evaluations (for CRAs under line management)

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