Manager, Central Monitoring, Data Analysis
Parexel
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Tech Stack
About the role
- Act as a subject matter expert for the configuration, implementation, and execution of Central Monitoring RBQM system across studies
- Maintain Central Monitoring Key Risk Indicators and Quality Tolerance Limit Libraries within Central Monitoring RBQM system
- Coordinate with functional and cross functional stakeholders to develop configuration specifications for Central Monitoring in RBQM system
- Provide operational expertise, training, and guidance as a point of escalation
- Conduct central monitoring reviews in support of study central monitor
- Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials
Requirements
- At least 4 years of relevant biotechnology/pharmaceutical industry experience
- Central Monitoring, site monitoring or data management experience a plus
- Minimum 2 years with direct RBQM systems experience
- Technical expertise in database design, system configuration, and report development
- Proficiency in programming languages such as Python, R, SQL, or SAS
- Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements
- Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures
- Proficiency in Microsoft Office applications, with advanced skills in Excel for data manipulation and reporting
Benefits
- Health insurance
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
database designsystem configurationreport developmentPythonRSQLSASdata managementquality control processesauditing procedures
Soft skills
operational expertisetrainingguidancecoordinationstakeholder engagement