Local Clinical Trial Manager - FSP

• Deliver clinical studies within time, budget, quality, protocol, contract, and regulatory expectations
• Lead local in-country study teams and provide matrix leadership and project management
• Act as operational point of contact between central and country study teams
• Support study feasibility, site selection, and local study performance
• Develop and maintain country study plans, budgets, forecasts, milestones, timelines, quality, and risk plans
• Monitor recruitment targets, patient recruitment cycle times, data quality, and audit/inspection readiness
• Provide troubleshooting and problem-resolution support
• Ensure site supplies and local inventory are managed
• Maintain accurate study systems and complete trial master files
• Report study progress and monitor key risk and performance indicators
• Develop country/site risk assessments and mitigation plans
• Review and approve monitoring visit reports
• Manage study budgets, site payments, vendors, contracts, and local resourcing
• Develop study documents, plans, manuals, informed consent forms, and local regulatory materials
• Coordinate regulatory authority and ethics committee submissions and approvals
• Maintain communication with regulatory authorities and ethics committees
• Maintain knowledge of the study compound, protocol, disease area, local treatment guidelines, and healthcare system
• Support audits and inspections and provide country responses and follow-up
• Train in-country staff and investigator sites and coordinate local study meetings
• Ensure communication and engagement with clinical sites
• Manage study-specific 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 stakeholders

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous CTM experience comparable to 1+ years experience in a CTM role
• Previous experience in Respiratory would be advantageous
• Experience in site monitoring
• Knowledge of clinical study, drug development, sample management, and associated processes and quality requirements
• Strong project management approach and ability to work and lead in a matrix team environment
• Understanding of country local regulations, ICH-GCP guidelines, and written standards
• Available and willing to travel for project-related activities as required
• Good English language written and verbal communication skills
• Proven negotiation skills
• Strong computer skills and willingness to learn new or evolving computer systems
• Ability to work effectively in a remote environment
• Ability to understand and apply digital innovations to clinical trials
• Conceptual, analytical, and strategic thinking including data literacy
• Problem-solving and conflict resolution skills
• Flexibility and learning agility

• Health and wellbeing support
• Healthy and balanced working environment
• Training courses to improve personal/professional skills
• Relevant study and protocol training
• Professional development opportunities
• Remote work environment
• Travel for project-related activities as required