Local Clinical Trial Manager – FSP

• Deliver clinical study results within contracted time, quality, and cost expectations
• Lead in-country clinical operations teams, cross-functional experts, vendors, and clinical site staff
• Act as operational point of contact between central and in-country study teams
• Conduct or support study feasibility, site selection, and local study performance management
• Develop and maintain country study plans, timelines, budgets, milestones, risks, and recruitment targets
• Troubleshoot and resolve study delivery issues
• Ensure supplies are available at sites and manage local supply inventory
• Maintain accurate study systems and complete trial master files
• Report study progress and monitor risk and performance indicators
• Develop risk assessments and mitigation plans
• Review and approve monitoring visit reports
• Create and manage study budgets, site payments, contracts, and local vendors
• Develop local study documents, plans, manuals, and informed consent forms
• Coordinate regulatory authority and ethics committee submissions and communications
• Maintain knowledge of the study compound, protocol, disease area, treatment guidelines, and healthcare system
• Support audits and inspections
• Train in-country staff and investigator sites and coordinate local study meetings
• Manage safety issues and safety report handling, including SAE reporting
• Coordinate end-of-study learning debriefs and identify improvements
• Collaborate with medical, legal, finance, regulatory, vendor, pharmacy, and ethics-board stakeholders

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 1+ years of experience in a CTM role
• Previous experience in site monitoring
• Oncology experience advantageous
• Equivalent combination of appropriate education, training and/or directly related experience may be considered
• Strong understanding of clinical study, drug development, sample management, and associated quality requirements
• Strong project management skills and ability to lead in a matrix team environment
• Understanding of country local regulations, ICH-GCP guidelines, and written standards
• Excellent English written and verbal communication skills
• Negotiation skills
• Strong computer skills and ability to learn evolving computer systems
• Ability to work effectively in a remote environment
• Willingness and availability to travel as required
• Ability to perform under pressure, prioritize, and handle multiple projects
• Ability to use and learn standard office equipment and technology

• Remote work arrangement
• Career development opportunities
• Training courses to improve personal/professional skills
• Accessibility accommodations during the application process