Lead CRA – Sponsor Dedicated, Fluent in German and English

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

📋 Description

• Establish and nurture robust relationships with clinical trial sites to improve both site and patient experiences while assisting in meeting enrollment objectives and key study milestones.

• Act as a representative for clinical development initiatives by engaging with investigators, sites, and research networks, while raising awareness of the company’s clinical pipeline.

• Conduct Monitoring Oversight Visits to assess the quality of CRA monitoring activities and evaluate site preparedness for regulatory inspections.

• Execute remote and on-site site qualification tasks as necessary to facilitate effective site selection.

• Lead or assist in Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs) to co-monitor studies, onboard new CRAs, and deliver practical training across oncology programs.

• Review and validate monitoring visit reports produced by CRAs to ensure they meet quality, completeness, and compliance standards.

• Analyze site performance and Key Risk Indicator (KRI) metrics to pinpoint emerging risks, drive issue resolution, and enhance ongoing study and site risk assessment strategies.

• Provide training and re-training to CRAs and site personnel on GCP, protocols, study-specific procedures, vendor requirements, and other essential trial documentation.

• Oversee and support site management operations, acting as a point of escalation for monitoring-related issues and ensuring effective execution of Corrective and Preventive Action (CAPA) plans.

• Ensure that all sites remain inspection-ready and assist sponsor activities during regulatory inspections or audits.

• Utilize CTMS and TMF systems to keep accurate study documentation, guarantee timely submission of essential documents, and conduct TMF reviews or audits as needed.

• Independently draft, review, or contribute to Clinical Site Monitoring Plans and other monitoring-related documents.

• Promote continuous improvement initiatives by developing or refining SOPs, work instructions, job aids, templates, and monitoring tools.

• Collaborate with stakeholders to enhance site selection, monitoring processes, oversight reporting, CTMS workflows, and EDC functionality through gap analysis, testing, and the implementation of process improvements.

• Build and sustain effective working relationships with investigators, site personnel, study teams, and CRA partners to ensure successful execution of studies.

⛳️ Requirements

• Bachelor's degree with generally 6+ years of pertinent clinical research experience, or a postgraduate degree with 4+ years of relevant experience.

• Significant experience monitoring oncology clinical trials, including solid tumor studies, with demonstrated expertise in Phase I oncology monitoring.

• Proven success in independently conducting remote and on-site monitoring visits, including site qualification, initiation, routine monitoring, and close-out activities.

• A minimum of two years of experience using Veeva systems, such as CTMS, CDMS, RTSM, and TMF.

• Direct experience in supporting sponsor and/or site inspections and ensuring inspection readiness.

• Experience in conducting site and TMF audits is highly preferred.

• Willingness to travel approximately 50–75% of the time, with the flexibility to increase travel based on business requirements or decrease when monitoring and oversight activities are conducted remotely.

🏝️ Benefits

• We are dedicated to developing our people through career advancement and progression, engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program.

• We are committed to fostering an inclusive culture where you can truly be yourself.