Clinical Trial Manager

Job not on LinkedIn

🕒 September 17

🇺🇸 United States – Remote

💵 $100k - $135k / year

⏰ 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

• Manage and oversee assigned clinical study duties and deliverables • Develop project documents, study start-up documents, Site Activation Plans, Monitoring Plans, tools, and training materials • Coordinate site identification, selection, recruitment, regulatory document collection, submissions, contracts, budgets, and investigator payments • Ensure compliance with approved protocols, ICH GCP, SOPs, and applicable regulatory requirements • Manage and train CRAs and study team members; oversee CRA performance, monitoring schedules, reports, expenses, timesheets, meetings, and handovers • Perform remote clinical data review in EDC systems and identify enrollment and data-entry trends • 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 and quality assessment visits as required • Attend client, investigator, kick-off, and project meetings • Provide input to project reviews, business proposals, bid defense meetings, and CRA performance appraisals • Assist CRAs with on-site audits when needed • Report to the Manager of Clinical Trial Management and/or Director, Study Start-Up in the US

🎯 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 • Dedication to quality in 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

🏖️ Benefits

• PTO • Comprehensive benefits • Fully remote work arrangement

Apply Now

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