Clinical Data Analyst Ii

Description
Position at Premier Research
Premier Research is looking for a Clinical Data Analyst II to join our Clinical Informatics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built with You. As an essential part of our team, you help us deliver medical innovation that patients are desperate for.
• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.

Together, we are Built for BiotechSM. Join us and build your future here.
What You'll Be Doing

• As an expert, utilize their previous broader clinical research experience and provide guidance to study team input to the development and update of the Risk Log for assigned projects.
• Provide direction to site monitors along with the Clinical Lead, for additional remote and on-site monitoring activities for sites at risk, within the scope of the trial monitoring and clinical management plans.
• Participate in the development of study specific analytics.
• Anticipate potential issues and resolve through potential action plans and documents corrective actions; provide direction to team members on complex study issues resolution.
• As a Subject Matter Expert, Clinical Data Analyst II conducts ongoing reviews of clinical trial data using various technologies, analytic and visualization tools to monitor the quality of data, patient safety and relevant risks as per the Risk Assessment for the study. This may include review via data listings, study specific eCRF and aggregated data through e-Premier tools.
• Develops Risk Analytics Monitoring Plan for assigned studies
• Responsible for monitoring site performance, data trending related to quality and site performance and escalation to the appropriate functional team lead through the regular use of e-Premier data visualization tools.

What We Are Searching For:

• In-depth knowledge of ICH/GCP regulations FDA Guidance Documents, EU Directives
• Ability to use analytical tools to extracting knowledge and insight from data (data mining)
• Bachelors in the biological sciences, computer sciences, mathematics, or data sciences and/or related disciplines in the health care domain. Masters preferred
• In-depth knowledge of clinical monitoring procedures
• 2-5 years Relevant experience in clinical research or related fields (Site-Operations, Monitoring On-site/Remote, Data Management, Hospital settings), global study experience, preferred.

Why Choose Premier Research?  

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. 
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.
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