Premier Research is looking for a Central Monitor I or II to join our Clinical Management 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.
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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.
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Your ideas influence the way we work, and your voice matters here.
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As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What You'll Be Doing:
- 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 Assessment 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 to the appropriate functional team lead through the regular use of ePremier data visualization tools
- As a Subject Matter 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
- Anticipate potential issues and resolve through potential action plans and documents corrective actions; provide direction to team members on complex study issues resolution
- Provide direction to site monitors along with the Clinical Lead, for additional remote and onsite monitoring activities for sites at risk, within the scope of the trial monitoring and clinical management plans
- Help to build efficiencies and the overall value from their previous broader clinical research experience and Risk Based Study Execution process at Premier
- Develops Risk Analytics Monitoring Plan for assigned studies
- Presents central monitoring findings to the internal team and sponsor teams on a predetermined frequency
What We Are Searching For:
- Bachelors in the biological sciences, computer sciences, mathematics, or data sciences and/or related disciplines in the health care domain. Masters preferred
- 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
- 2-3 years Clinical research experience (site operations, monitoring On-site/Remote data management), global study experience, preferred
- Ability to use analytical tools to extracting knowledge and insight from data (data mining)
- In-depth knowledge of ICH/GCP regulations FDA Guidance Documents, EU Directives
- In-depth knowledge of clinical monitoring procedures
- Fluent verbal and written English and presentation skills for business communication
- Must have proven track record of successful delivery, including effective management, multitasking and understanding of data, and accountability for quality and timelines
- Mentoring and guidance to other team members
- Ability to travel < 10%