Local Clinical Trial Manager

• Accountable for achieving final clinical deliverables within contracted timelines
• Lead the local study team and manage study activities within Denmark and other assigned countries
• Serve as the operational point of contact between central and in-country study teams
• Conduct study feasibility, site selection, and oversee local study performance
• Deliver studies on time, within budget, and to quality expectations under applicable regulations and guidelines
• Develop and maintain country study plans, budgets, resource estimates, milestones, timelines, and risk plans
• Troubleshoot and resolve study-team issues and ensure site supplies and inventory
• Maintain accurate study systems and trial master files and report progress to stakeholders
• Monitor risk and performance indicators and review study databases for accuracy
• Review and approve monitoring visit reports and ensure monitoring activities are completed
• Manage local vendors, contracts, payments, communications, and issue resolution
• Develop study documents, plans, manuals, informed consent forms, and regulatory submissions
• Maintain communication with regulatory authorities and ethics committees
• Support audits, inspections, regulatory compliance, and corrective follow-up
• Coordinate training, investigator meetings, monitor meetings, and local study meetings
• Manage safety issues and safety report handling, including SAE reporting
• Collaborate with medical, legal, finance, regulatory, vendor, site, and external investigator stakeholders
• Participate in end-of-study learning debriefs and identify process improvements
• Travel as needed for the role

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 3+ years of comparable experience
• Experience in site monitoring
• Knowledge of clinical study, drug development, sample management, and associated processes and quality requirements
• Strong project management skills and ability to work and lead in a matrix team environment
• Understanding of country local regulations and, if required, other countries' regulations, ICH-GCP guidelines, and written standards
• Strong English written and verbal communication skills
• Negotiation skills
• Strong computer skills and ability to learn new or evolving computer systems
• Ability to work effectively in a remote environment
• Willingness and availability to travel for project-related activities
• Ability to understand and apply digital innovations to clinical trials
• Conceptual, analytical, strategic thinking, and data literacy
• Problem-solving and conflict resolution skills
• Flexibility, resilience, and high learning agility

• Health and wellbeing support
• Accessibility services and accommodations for job seekers with disabilities
• Equal employment opportunity and affirmative action employer
• Remote work arrangement