Senior Clinical Research Associate (CRA) – Animal Health
在 Elanco (NYSE:ELAN) 一切都从动物开始!作为全球动物健康领导者,我们致力于创新和提供农场动物和物疾病预防和治疗的产品和服务。在 Elanco,我们以我们的食品与伙伴关系丰富生活愿景以及我们的目标为动物,客户,社会和人民而言所做的一切做出了更多努力。在 Eranco,我们自豪地培养多样化和包容的工作环境。我们相信多样性是创新的驱动力,创造力和整体商业成功。在这里,你将成为一个公司的一部分,它重视和支持新的思维方式,与动态的人员合作,并获得新技能和经验,这将推动你的职业生涯到新的高度。使动物生活更好让生活更好!今天加入我们的团队!你的角色:高级临床研究合伙人 (CRA) 动物健康作为高级临床调查合伙人 在此职位上,你将负责指导和执行实验室和现场研究的关键临床监测,与项目团队和 CRO 合作以确保我们的研究结果符合全球监管标准并推动成功的产品登记。你的责任:· 监督农业和伴侣动物临床试验的监控和执行,确保所有活动都遵守全球监管规范 (GCP/VICH) 和内部政策。· 作者和执行全面的监测计划;根据研究要求进行现场合格,启动,例行监测和近距离访问。· 执行全面的数据审查 (QC) 和查询解决方案,以确保所有分配研究和项目中最高水平的数据完整性和质量。· 作为调查网站和第三方组织 (CRO) 的首要联系人,监督研究地点文档,研究材料运输和药品问责制。· 与包括监管事务和数据管理在内的跨职业合作伙伴合作,支持协议开发,学习规划以及最终研究报告和提交文件的发展。你需要取得成功的是什么 (最低资格): · 专业教育和经验:科学或健康相关领域的学士学位,具有5年以上适用职业历程
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At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Your Role: Senior Clinical Research Associate (CRA) – Animal Health
As a Senior Clinical Research Associate (CRA) – Animal Health , you will be a key member of our Global Clinical Development Sciences team, dedicated to advancing Elanco’s portfolio of Farm Animal and Pet Health products. In this role, you will be responsible for guiding and executing crucial clinical monitoring for laboratory and field studies, partnering with project teams and CROs to ensure our study results meet global regulatory standards and drive successful product registrations.
Your Responsibilities:
- Oversee the monitoring and execution of farm and companion animal clinical trials, ensuring all activities comply with global regulatory standards (GCP/VICH) and internal policies.
- Author and execute comprehensive monitoring plans; conduct site qualification, initiation, routine monitoring, and close-out visits in accordance with study requirements.
- Perform thorough data review (QC) and query resolution to ensure the highest level of data integrity and quality across all assigned studies and projects.
- Serve as the primary contact for investigator sites and third-party organizations (CROs), overseeing study site documentation, investigational material shipments, and drug accountability.
- Collaborate with cross-functional partners, including Regulatory Affairs and Data Management, to support protocol development, study planning, and the development of final study reports and submission files.
What You Need to Succeed (minimum qualifications):
- Education & Experience:A Bachelor's degree in a science or health-related field with 5+ years of applicable experience, OR a Master’s degree in a science or health-related field with 3+ years of applicable experience.
- Clinical Trial Experience:Proven experience monitoring single-site or multi-site clinical field studies for safety and effectiveness.
- Key Skills:Demonstrated interpersonal skills with the ability to work within and across interdisciplinary teams, combined with a strong knowledge of animal health concepts and global clinical trial regulations.
What will give you a valuable edge (preferred qualifications):
- Direct experience with regulatory authority submissions and a deep understanding of the data requirements for successful filings.
- Experience acting as a lead monitor or mentor for other Clinical Research Associates on clinical projects.
- Advanced proficiency in clinical trial management systems, such as Veeva Vault, and other collaborative tools.
- Specialized experience in either Farm Animal or Pet Health clinical studies.
- Proven ability to anticipate issues and proactively ensure innovative solutions in a fast-paced, matrixed environment.
Additional Information:
- Travel:Up to ~50%
- Location:US - Teleworker
Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose!
Some highlights include:
- Multiple relocation packages
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
Originally posted on Himalayas