Senior Clinical Trial Manager

• Lead delivery of clinical study site management activities through coordination of clinical staff on complex studies
• Ensure site qualification, initiation, interim monitoring, site management and study close-out activities comply with study protocols and plans
• Provide leadership and direction to clinical site management team members from study start through closure
• Oversee regional CTMs and coordinate efforts across the CTM team
• Represent Site Management issues at sponsor, investigator and bid defense meetings
• Contribute to project plans and formulate global monitoring strategies
• Provide input to project tracking systems, financial performance reports, study metrics, resource allocation and time recognition
• Collaborate with Business Development, Regulatory, Study Start-up and Project Management
• Assume a dual PM/CTM role when needed
• Develop, maintain and ensure compliance with Clinical Monitoring Plans, budgets, study tools and site visit reports
• Train and manage CRA teams on clinical aspects of studies
• Develop and implement recruitment strategies and track enrollment
• Improve site data quality, review data metrics and address issues with action plans
• Review data trends and trip report issues and escalate concerns
• Oversee TMF compliance and inspection readiness
• Forecast site visits and ensure staffing needs and backlogs are addressed
• Set performance expectations and mentor or coach colleagues and clinical project staff
• Perform co-monitoring and site visits as required
• Support inspections by health authorities and sponsor audits
• Proactively identify and mitigate risks
• Perform other duties as assigned

• Four-year college curriculum or equivalent with a major concentration in biological, physical or health studies, and a minimum of four years as a Senior Clinical Research Associate (or equivalent)
• OR two-year college curriculum or equivalent education/training and a minimum of six years as a Senior Clinical Research Associate
• Minimum 2 years relevant experience as a CTM/LCRA (or equivalent), including overseeing a CTM team
• Travel required
• Valid current passport required
• Driving license required
• Excellent oral and written communication skills in English
• Strong understanding of FDA and/or EU Directive regulations, ICH Guidelines and local regulatory requirements
• Proficient knowledge of Microsoft Office, eCRF and IVRS packages
• Proficiency with IxRS, CTMS and EDC systems
• Thorough understanding of clinical research principles and processes
• Experience and understanding of therapeutic areas sufficient to function as CTM
• Deep understanding of standard operating procedures
• Excellent planning, organizational, interpersonal and presentation skills
• Ability to lead and motivate teams remotely across time zones

• Diverse and inclusive work environment
• Supportive and cohesive teams
• Leadership accessibility
• Equal employment opportunities
• Mentoring and coaching opportunities