Local Clinical Trial Manager

This is a fully remote position, open to applicants in Denmark.

📋 Description

• Responsible for meeting final clinical deliverables within agreed timelines.

• Lead the local study team and oversee study activities in Denmark and other designated countries.

• Act as the operational liaison between central and local study teams.

• Conduct feasibility studies, select sites, and monitor local study performance.

• Execute studies punctually, within budget, and to quality standards in accordance with relevant regulations and guidelines.

• Develop and manage country-specific study plans, budgets, resource estimates, milestones, timelines, and risk management plans.

• Address and resolve issues within the study team while ensuring site supplies and inventory are maintained.

• Keep study systems and trial master files up to date, and report progress to stakeholders.

• Track risk and performance metrics and review study databases for accuracy.

• Review and approve monitoring visit reports, ensuring that monitoring activities are completed.

• Oversee local vendors, contracts, payments, communications, and issue resolution.

• Create study documents, plans, manuals, informed consent forms, and regulatory submissions.

• Maintain ongoing communication with regulatory authorities and ethics committees.

• Assist with audits, inspections, regulatory compliance, and necessary corrective actions.

• Organize training sessions, investigator meetings, monitor meetings, and local study gatherings.

• Manage safety concerns and the handling of safety reports, including SAE reporting.

• Collaborate with medical, legal, finance, regulatory, vendor, site, and external investigator stakeholders.

• Engage in end-of-study learning debriefs to identify opportunities for process enhancements.

• Travel as necessary for the role.

⛳️ Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualifications.

• Minimum of 3 years of relevant experience.

• Experience in site monitoring.

• Familiarity with clinical studies, drug development, sample management, and related processes and quality standards.

• Strong project management capabilities and the ability to work and lead within a matrix team structure.

• Knowledge of local country regulations, and if necessary, regulations from other countries, ICH-GCP guidelines, and written standards.

• Excellent written and verbal communication skills in English.

• Proficient negotiation skills.

• Strong computer skills with the capacity to learn new or evolving systems.

• Ability to work effectively in a remote setting.

• Willingness and availability to travel for project-related activities.

• Aptitude for understanding and applying digital innovations in clinical trials.

• Strong conceptual, analytical, strategic thinking skills, and data literacy.

• Proficient problem-solving and conflict resolution abilities.

• Flexibility, resilience, and a high capacity for learning agility.

🏝️ Benefits

• Health and wellbeing support.

• Accessibility services and accommodations for job seekers with disabilities.

• Equal employment opportunity and affirmative action employer.

• Remote work arrangement.