Local Clinical Trial Manager – FSP

• Lead the within-country clinical operations study team and manage study activities in Denmark
• Serve as the operational point of contact between central and country study teams
• Support study feasibility and site selection; lead site selection and remain accountable for local study performance
• Deliver assigned studies within time, budget, quality, protocol, regulatory, and ICH-GCP requirements
• Develop and maintain country study plans, forecasts, budgets, milestones, timelines, quality plans, and risk plans
• Monitor recruitment targets, patient recruitment cycle times, data quality, and audit/inspection quality
• Provide troubleshooting and problem-resolution support and manage local site supply inventory
• Ensure accuracy of study systems and completeness of the trial master file
• Report study progress to study teams and stakeholders; monitor risk and performance indicators
• Develop country/site risk assessments, mitigation plans, and escalation processes
• Review and approve monitoring visit reports and ensure required site monitoring activities are completed
• Manage study budgets, expenditures, site payments, local vendors, contracts, and negotiations
• Develop key study documents, plans, manuals, local informed consent forms, and required licenses
• Coordinate clinical study application submissions to regulatory authorities and ethics committees
• Maintain communication with regulatory authorities and ethics committees throughout the study
• Maintain knowledge of the study compound, protocol, disease area, competitive landscape, treatment guidelines, and healthcare system
• Support audits and inspections and provide country responses and follow-up
• Coordinate and deliver investigator meetings, monitor meetings, and local training
• Ensure appropriate training of country staff and investigator sites
• Manage protocol amendment communications, study-specific safety issues, and SAE reporting
• Coordinate end-of-study learning debriefs and identify improvements
• Collaborate with medical, legal, finance, regulatory, supply, vendor, and other functional teams
• 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
• Experience and knowledge sufficient to perform the role; equivalent combinations of education, training, and directly related experience may be considered
• Strong understanding of clinical studies, drug development, sample management, and associated quality requirements
• Strong project management skills and ability to work in a matrix team environment
• Understanding of local country regulations, ICH-GCP guidelines, and written standards
• Excellent English written and verbal communication skills
• Negotiation skills
• Strong computer skills and willingness to learn evolving computer systems
• Ability to work effectively in a remote environment
• Ability and willingness to travel for project-related activities as required
• Ability to apply conceptual, analytical, and strategic thinking, including data literacy
• Effective problem-solving and conflict-resolution skills
• Ability to understand and apply digital innovations to clinical trials
• Ability to perform under pressure while prioritizing and handling multiple projects
• Ability to communicate and work with diverse groups, including physicians, scientists, ethics boards, pharmacies, vendors, and clinical site staff

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Career development and training opportunities
• Participation in relevant training courses to improve personal/professional skills
• Accessibility accommodations for job seekers with disabilities
• Equal employment opportunity and affirmative action environment