Senior Clinical Research Associate

• Conduct site monitoring responsibilities for clinical trials independently
• Provide oversight, leadership, and guidance to CRA teams
• Ensure adherence to project scope, SOPs, timelines, budgets, protocol, GCP, and regulatory requirements
• Review monitoring visit reports and conduct co-monitoring and evaluation visits
• Ensure timely investigator site visits
• Coordinate cross-functional issue resolution for clinical trial monitoring
• Assist with Monitoring Plans, training presentations, ethics documents, and site contract negotiation
• Provide monthly billing information to finance
• Manage study budgets and act as sponsor referent for stand-alone projects
• Perform qualification, initiation, interim, and close-out visits remotely and onsite
• Prepare accurate monitoring visit reports covering site issues, resolutions, protocol deviations, study progress, and enrollment
• Verify source documents and CRF data integrity
• Perform quality control of eTMF/TMF documents and investigational product accountability
• Review site regulatory binders
• Maintain site contact, assess patient accrual, and respond to sponsor requests
• Facilitate adverse event reporting and SAE reconciliation
• Resolve discrepant data queries with in-house CRAs, CTC, and data management
• Identify site issues and develop problem-solving strategies
• Prepare study sites for audits
• Mentor and train CRAs, including new-hire onboarding
• Collaborate on CTMS development and maintenance
• Manage conflicting priorities and perform additional assigned duties

• Minimum 3 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry
• Ability to autonomously manage monitoring activities
• Oncology experience
• Availability to travel in Belgium and Netherlands
• 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 problem-solve unstructured or ambiguous challenges
• Strong command of the local language, written and verbal, in the country where monitoring activities are performed
• 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, and local regulations
• Knowledge of regulatory and ethical requirements
• Ability to establish and maintain positive relationships with Sponsor, Site, and Project Team members
• Graduation in a scientific health field
• Adequate English
• Bachelor's degree in Biology, Biotechnology, Life Sciences, Pharmacy, or related scientific health field

• Remote work
• Regular employment contract