Senior CRA/CRA II, Oncology Trials

🕒 2 days ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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

• Support a client as a Clinical Research Associate in oncology clinical trials • Execute traditional on-site monitoring activities across all phases of development • Perform full source data verification and investigational product accountability • Ensure compliance with ICH/GCP and regulatory requirements • Manage clinical trial visit activities efficiently • Produce accurate, comprehensive, and timely monitoring visit and trip reports • Use CTMS platforms to support monitoring and clinical operations • Collaborate with sites and stakeholders to maintain trial integrity and success • Identify and resolve issues proactively in fast-paced development environments • Support quality execution, accelerated timelines, and regulatory submissions

🎯 Requirements

• Strong background in oncology clinical trials across all phases of development, including early phase/first in human studies, safety, PK/PD, and dose escalation designs • Hands-on experience supporting solid tumor indications such as melanoma, breast, ovarian, prostate, and lung cancer • Proficiency in traditional on-site monitoring models, including full source data verification, investigational product accountability, and adherence to ICH/GCP and regulatory requirements • Proven track record of efficiently managing visit activities and producing accurate, comprehensive, and timely monitoring visit and trip reports • Extensive experience with CTMS platforms such as Siebel CTMS, Veeva Vault CTMS, Medidata CTMS, Oracle Clinical/Clinical One, or similar systems • Fluency in English and German strongly preferred • Professionalism, attention to detail, reliability, ethical decision-making, communication, teamwork, adaptability, digital fluency, customer focus, and proactive problem-solving • Prior exposure to investigational products involving TLR pathways, PARP1 inhibitors, or Werner helicase protein desirable but not required • Equivalent experience, skills, and/or education may be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Remote work arrangement (Remote (Pre-Approved))

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