Clinical Trial Manager

• Develop the Site Activation Plan 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
• Manage clinical deliverables, project milestones, timelines, and deficiencies
• Train, delegate, and oversee CRAs and other study team members
• Develop Monitoring Plans, tools, and training materials
• Oversee monitoring visit schedules and CRA performance
• Review and approve visit reports, follow-up letters, expenses, and timesheets
• 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, scope changes, and invoice review
• Perform monitoring of assigned sites and assist with on-site audits
• Attend and contribute to investigator, kick-off, client, and project meetings

• Excellent written and verbal communication, presentation skills, conflict management, time management, organizational, interpersonal, and problem-solving skills
• Knowledge of project management techniques and tools and proficient 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 experience in personnel management preferred
• Previous experience as a CRA preferred