Description
Syneos Health is seeking a Senior CRA/CRA II with a strong background in oncology clinical trials across all phases of development.
The ideal candidate will have hands-on experience supporting solid tumor indications such as melanoma, breast, ovarian, prostate, and lung cancer, and will be comfortable operating in fast-paced development environments where quality execution supports accelerated timelines and regulatory submissions.
Responsibilities:
- Demonstrated proficiency in traditional on-site monitoring models, including full source data verification, investigational product accountability, and strict adherence to ICH/GCP and regulatory requirements.
- Proven track record of managing visit activities efficiently while producing accurate, comprehensive, and timely monitoring visit and trip reports.
- Extensive experience working within CTMS platforms such as Siebel CTMS, Veeva Vault CTMS, Medidata CTMS, Oracle Clinical/Clinical One, or similar systems.
- Multilingual capabilities, particularly fluency in English and German, are strongly preferred.
Requirements:
- Oncology expertise across all phases of development
- Indication-specific knowledge: solid tumor
- Traditional monitoring model: solid skills and proficiency in on-site monitoring, full source data verification, IP accountability, and regulatory compliance
- Trip report writing: proven track record in producing accurate, comprehensive, and timely monitoring visit reports, with extensive experience using any CTMS platform
- Additional skills: multilingual - English and German
Culture-specific and desired soft skills:
- Mission-focused and intellectually curious: a collaborative mindset with a passion for pushing boundaries and tackling complex challenges to create solutions that matter
- Collaborative and adaptable mindset: strong professionalism (ethics, detail focus, reliability) with excellent collaboration (communication, teamwork, building trust) and adaptability to a fast-paced environment (sense of urgency for the mission), emphasizing quality, digital fluency (CTMS, eTMF, remote tools), and customer service to sites and sponsors, all while maintaining a proactive, problem-solving mindset to ensure trial integrity and success