Clinical Data Analyst II - Remote

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases. 

We’re looking for an exceptional Clinical Data Analyst II to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.  

• Examine data in a graphical format to obtain insight regarding the information within the data
• Conduct 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 Log for the study. This may include review via data listings, study specific eCRF and aggregated data through ePremier tools
  Is responsible for monitoring site performance, data trending related to quality and site performance and escalation of those sites not meeting expectations through the regular use of ePremier data visualization tools
• Utilize their previous central monitoring experience and provide input to the development and update of the Risk Log for assigned projects
• Assist the study project team with development of the escalation path and action plan when risks are identified in the data for assigned projects
• Liaise with and maintains effective and timely communication with all team members and documents all communication; attend routine project team calls to discuss findings as appropriate
• Anticipate potential issues and resolve through potential action plans and documents corrective actions; seek direction from team members on more complex study issues
• Review the effectiveness of the recommended actions and escalate for further appropriate actions if no effect is first observed
• 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 plan
• Serve as resource to study sites in resolving queries and/or other identified data collection issues
• Perform remote/phone visits, as required per the CMP and contracted services
• Help to build efficiencies and the overall value from their monitoring experience and Risk Based Study Execution process at Premier
• Other activities as designated​

• Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, scientific, or health related field
• 2-5 years clinical monitoring experience, global experience preferred
• 1-3 years experience in applied business intelligence – i.e. reviewing and analyzing data in order to present information in an understandable and usable format
• Exposure to process of extracting knowledge and insight from data (data mining) in any scientific or technology field
• Knowledge of ICH/GCP regulations
• Knowledge of FDA Guidance Documents/EU Directives/ICH GCP/device development, and clinical monitoring procedures
• Knowledge of web-based communication tools
• Fluent verbal and written English as well as the local language(s) if required for clinical trial submissions
• Must have proven track record of successful delivery, including effective management and understanding of data, and accountability for quality and timelines
• Ability to multitask and work effectively in a fast-paced environment with changing priorities
• Strong verbal and written communication and negotiation skills and confidence to act on own initiative.
• Excellent organizational and time-management skills, able prioritize work to meet deadlines
• Ability to travel up to 10%