Lead CRA - Sponsor dedicated - Fluent in German and English - Based in Belgium

Lead CRA - Sponsor dedicated - Fluent in German and English - Based in Belgium

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

• Build and maintain strong relationships with clinical trial sites to enhance the site and patient experience while supporting enrollment goals and key study milestones.
• Serve as an ambassador for clinical development programs by engaging investigators, sites, and research networks and promoting awareness of the company’s clinical pipeline.
• Conduct Monitoring Oversight Visits to evaluate the quality of CRA monitoring activities and assess site readiness for regulatory inspections.
• Perform remote and on-site site qualification activities as needed to support efficient site selection.
• Lead or support Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs) to co-monitor studies, onboard new CRAs, and provide hands-on training across oncology programs.
• Review and approve monitoring visit reports generated by CRAs to ensure quality, completeness, and compliance.
• Analyze site performance and Key Risk Indicator (KRI) metrics to identify emerging risks, drive issue resolution, and contribute to the ongoing enhancement of study and site risk assessment strategies.
• Deliver training and re-training to CRAs and site personnel on GCP, protocols, study-specific procedures, vendor requirements, and other critical trial documentation.
• Provide oversight and support for site management activities, serving as an escalation point for monitoring-related issues and ensuring effective implementation of Corrective and Preventive Action (CAPA) plans.
• Ensure all sites maintain inspection readiness and support sponsor activities during regulatory inspections or audits.
• Leverage CTMS and TMF systems to maintain accurate study documentation, ensure timely filing of essential documents, and conduct TMF reviews or audits as required.
• Independently author, review, or contribute to Clinical Site Monitoring Plans and other monitoring-related documentation.
• Drive continuous improvement initiatives by developing or refining SOPs, work instructions, job aids, templates, and monitoring tools.
• Partner with stakeholders to optimize site selection, monitoring processes, oversight reporting, CTMS workflows, and EDC functionality through gap analysis, testing, and implementation of process improvements.
• Establish and maintain effective working relationships with investigators, site personnel, study teams, and CRA partners to ensure successful study execution.

Qualifications:

• Bachelor's degree with typically 6+ years of relevant clinical research experience, or a postgraduate degree with 4+ years of related experience.
• Extensive experience monitoring oncology clinical trials, including solid tumor studies, with proven Phase I oncology monitoring expertise.
• Demonstrated success independently conducting remote and on-site monitoring visits, including site qualification, initiation, routine monitoring, and close-out activities.
• At least two years of experience using Veeva systems, including CTMS, CDMS, RTSM, and TMF.
• Direct experience supporting sponsor and/or site inspections and ensuring inspection readiness.
• Experience conducting site and TMF audits is highly desirable.
• Willingness to travel approximately 50–75% of the time, with flexibility to increase travel based on business needs or decrease when monitoring and oversight activities are conducted remotely.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.