Clinical Trial Manager – Oncology

• Lead delivery of clinical study site management activities through coordination of Clinical staff within a geographic region
• Ensure site qualification, initiation, interim monitoring, site management, and study close-out activities comply with the protocol, study plan, and Worldwide SOPs
• Ensure quality and timeliness of clinical deliverables for assigned programs or regions
• Collaborate with Project Management to establish site-management targets and monitoring strategy
• Provide leadership and direction to clinical site-management team members from study start through closure
• Serve as primary Site Management contact for clinical monitoring and site activities
• Manage monitoring deliverables, study budgets, out-of-scope activities, and quality-management documents such as Clinical Monitoring Plans
• Oversee compliance with the Clinical Monitoring Plan, site visits, trip reports, follow-up letters, protocol deviations, and visit action items
• Train CRAs on clinical aspects of studies
• Develop and implement patient-recruitment strategies and track enrollment
• Improve site-data quality, review data metrics, and address issues with action plans
• Track site-management deliverables, trends, analytics, financial performance, resources, and time recognition
• Oversee Trial Master File compliance and inspection readiness
• Formulate regional monitoring strategy and forecast site visits and staffing needs
• Review and finalize trip reports
• Perform site qualification, initiation, interim monitoring, and close-out visits as needed
• Escalate monitoring and site issues, propose solutions, and mitigate risks
• Represent Site Management as primary project contact when needed
• Conduct co-visits to ensure site, CRA, and study-procedure quality

• Excellent interpersonal, oral and written communication skills in English; Portuguese preferred
• Excellent planning, organizational, presentation, and time-management skills
• Ability to manage multiple tasks, negotiate diplomatically, prioritize, plan proactively, and work with minimal supervision
• Ability to lead and motivate a team remotely
• Experience and input into monitoring and site management process initiatives
• Strong customer focus and professional sponsor interaction
• Extensive understanding of clinical research principles and processes
• Strong understanding of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements
• Experience in the study therapeutic indication/area
• Thorough understanding of standard operating procedures
• Proficient knowledge of Microsoft Office, eCRF, and IVRS packages
• Proficiency with IxRS, CTMS, and EDC systems
• Four-year college curriculum or equivalent with a major concentration in biological, physical, or health studies and at least three years as a Senior Clinical Research Associate (or equivalent), OR two-year college curriculum or equivalent education/training and at least five years as a Senior Clinical Research Associate, or at least six months functioning as CTM/LCRA (or equivalent) while supporting the main CTM and coordinating clinical operations activities
• Valid current passport required
• Driving license required
• Travel required

• Equal employment opportunity
• Diverse and inclusive work environment
• Supportive, team-oriented atmosphere
• Hands-on, accessible leadership
• Professional growth and opportunity to succeed