Clinical Trial Manager

Job not on LinkedIn

🔥 7 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Logo of Linical

Linical

501 - 1000 employees

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Linical is a global Clinical Research Organization (CRO) that partners with biopharmaceutical companies to manage and support clinical trials across various therapeutic areas such as oncology, neurology, psychiatry, immunology, and endocrinology. With extensive expertise in drug development strategy, protocol development, regulatory consulting, and patient recruitment, Linical guides clients through every phase of their clinical development journey. They emphasize quality data capture, personalized service, and overcoming obstacles to ensure successful clinical trials, helping to bring new therapies to patients worldwide. Linical's global reach and award-winning services make them a reliable partner for conducting complex clinical studies.

📋 Description

• Develop site activation plans and customize study start-up documents • Coordinate site identification, selection, and recruitment • Oversee regulatory document collection, review, and ethics submissions • Prepare and review essential study documents • Authorize release of investigational product • Coordinate site contracts and budget negotiations and manage investigator payments • Manage clinical deliverables, milestones, timelines, and deficiencies • Communicate with project managers, clients, and study teams • Manage and train CRAs and other study team members • Develop monitoring plans, tools, and training materials • Oversee monitoring visit schedules and review visit reports, follow-up letters, expenses, and timesheets • Perform quality assessment visits and remote clinical data review in EDC systems • Conduct TMF quality-control reviews and ensure regulatory documents are filed appropriately • Manage clinical vendor budgets, contracts, deliverables, and quality • Assist with study budgets, expenses, revenue recognition, invoices, scope changes, and client notifications • Perform site monitoring as required and attend investigator, kick-off, client, and project meetings • Assist CRAs with on-site audits when needed • Contribute to proposals, bid defense meetings, performance appraisals, and department training initiatives as applicable

🎯 Requirements

• Excellent written and verbal communication, presentation, conflict management, time management, organizational, interpersonal, and problem-solving skills • Knowledge of project management techniques and tools and proficiency in project management software • Strong team-building skills and ability to work successfully in a matrixed team environment • Excellent customer service and relationship-building skills • Excellent working knowledge of ICH, GCP, and local guidelines/regulations • Knowledge of all aspects of clinical trial conduct, including systems, study financials, and procedures • Ability to prioritize and manage multiple tasks and delegate responsibility as necessary • Dedication to quality in all work tasks and deliverables • Working knowledge of computer systems, applications, and operating systems • Life Science degree, nursing background and/or combination of education/experience • Minimum three years of clinical trial management experience • Previous personnel management experience preferred • Previous CRA experience preferred

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