Senior Clinical Research Associate

• Conduct site monitoring responsibilities independently for clinical trials
• Provide oversight, leadership, and guidance to CRA teams
• Ensure adherence to project scope, SOPs, timelines, budgets, protocol, and GCP requirements
• Review monitoring visit reports and conduct co-monitoring and evaluation visits
• Coordinate cross-functional resolution of clinical trial monitoring issues
• Assist with Monitoring Plans, training presentations, ethics documentation, and site contract negotiations
• Perform qualification, initiation, interim, and close-out visits remotely and onsite
• Prepare accurate monitoring visit reports covering site problems, resolutions, protocol deviations, study progress, and enrollment
• Review source documents and verify CRF data integrity
• Perform quality control of eTMF/TMF documents and investigational product accountability
• Review site regulatory binders and maintain contact with study sites
• Monitor patient accrual and respond to sponsor requests
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
• Resolve discrepant data queries with CRAs/CTC and data management
• Identify site issues and develop problem-solving strategies
• Prepare sites for audits
• Participate in internal, client/sponsor, scientific, and other meetings
• Train and mentor new CRAs
• Collaborate on CTMS development and maintenance
• Provide monthly billing information and manage study budgets for stand-alone projects
• Manage conflicting priorities and perform additional assigned duties

• Minimum 4 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry
• Ability to autonomously manage monitoring activities
• Oncology experience
• Availability to travel in Denmark and Sweden
• Fluent in Danish, Swedish and English
• Quality focused; careful, thorough, and detail-oriented
• Strong organizational skills and ability to multi-task in a fast-paced environment
• Ability to manage priorities, organize time, and solve problems
• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
• Ability to travel and manage stress
• Professional, trustworthy, and disciplined
• Ability to solve unstructured or ambiguous challenges
• Strong command of local language and English for EU monitoring activities
• Excellent communication and interpersonal skills with customer service orientation
• Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture
• Knowledge of clinical research, ICH GCP, local regulations, regulatory and ethical requirements
• Ability to establish and maintain positive relationships with sponsors, sites, and project team members
• Graduation in a scientific health field
• Bachelor's degree in Biology, Biotechnology, Life Sciences, Pharmacy, or related scientific health field

• Remote work arrangement
• Part-time schedule
• Contingency Workforce contract