Lead CRA – Sponsor Dedicated, Fluent in German and English

🔥 2 hours ago

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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.