Clinical Trial Manager
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Job Description
Clinical Trial Manager overseeing study start-up, CRAs, vendors, budgets, and clinical deliverables. Supporting Linical’s CRO mission to provide clinical-trial expertise.
Responsibilities:
- 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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