Clinical Team Manager – Country Study Manager

• Lead and manage operational implementation of country feasibility, planning, and delivery of Phase I–IV clinical studies
• Serve as the operational point of contact between the Central Study Team and in-country staff
• Deliver studies within the country according to protocol, timelines, budget, quality, and risk requirements
• Provide input into study concepts, protocols, logistics, and local expert coordination
• Assess study appropriateness for the local environment and conduct country/site feasibility
• Lead site selection and remain accountable for site performance
• Develop and maintain country study plans, forecasts, budgets, resource estimates, milestones, timelines, quality plans, and risk plans
• Select and manage local vendors, including oversight, agreements, payments, communications, and issue management
• Manage study budgets, expenditures, site payments, and accrual reporting to Finance
• Manage key study documents, plans, manuals, local recruitment materials, and site support materials
• Develop country/site risk assessments, mitigation plans, and management communications
• Assist with ethics committee/IRB submissions and, where applicable, Regulatory Authority submissions and approvals
• Arrange translations of key study documents into the local language
• Support and negotiate Clinical Trial Agreements with investigational sites
• Ensure site supplies and manage local supply inventory
• Coordinate in-country operational activities, site progress, protocol deviations, metrics, communications, escalation, and monitoring-plan compliance
• Build relationships with local medical staff and key partners
• Coordinate and deliver investigator meetings, monitor meetings, and local training
• Ensure study quality and integrity through appropriate business management monitoring activities
• Support regulatory/compliance audits and follow up on assessment and audit reports
• Review monitoring tracking tools, risk and performance indicators, reports, and study databases for accuracy
• Escalate resourcing issues and ensure appropriate in-country staffing
• Review and approve Monitoring Visit Reports within agreed timelines
• Manage and report study-specific safety issues, including SAE reporting
• Ensure studies comply with applicable regulations, ICH/GCP, and client standards
• Maintain accurate Sponsor Study Records
• Coordinate end-of-study/program learning debriefs and identify improvements
• Maintain therapeutic-area, product, protocol, ICH-GCP, and client-standard knowledge through ongoing training
• Collaborate with country study staff, medical staff, physicians, scientists, ethics boards, pharmacies, and vendors

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job
• Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered
• Good leadership, mentoring, and team motivation skills
• Good planning and organizational skills
• Solid interpersonal and problem-solving skills in a multicultural matrix organization
• Ability to work effectively in changing environments with complex or ambiguous situations
• Familiarity with clinical monitoring practices, processes, and requirements
• Good judgment and decision-making skills
• Effective oral and written communication skills, including English language proficiency
• Ability to evaluate workload against project budgets and adjust resources accordingly
• Financial acumen and knowledge of budgeting, forecasting, and fiscal management
• Strong attention to detail
• Understanding of relevant regulations, including ICH/GCP and FDA guidelines
• Strong computer skills, including Outlook, Excel, Word, and computerized applications
• Ability to travel domestically and internationally and frequently drive to site locations
• Knowledge of country local regulations, ICH-GCP guidelines, and client written standards

• Fully remote work mode
• Standard Monday–Friday work schedule
• Training courses and opportunities to improve personal/professional skills
• Global team collaboration and professional development
• Travel opportunities for project-related activities, including domestic and international travel