Opportunity to work as Compliance Specialist in Icon Clinical Research
ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: Compliance Specialist - 008156
Responsible for ensuring quality compliance is maintained within the Interactive Technologies division during both the project development phase and the maintenance phase.
Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 0%) domestic andlor international.
• Perform Quality Management Review (OMR) on active projects.
• Extract and review study data from the SOL database to ensure accuracy according to system specifications and client requirements.
• Identify gaps and inconsistencies in data. Make rational judgements from available information and analysis.
• Communicate with department management and project managers regarding quality andlor compliance issues and trends.
• Ensure projects adhere to the System Development life Cycle (SDLC).
• Conduct final review of new system installations.
• Conduct accurate and timely secondary review of OMRs.
• Act as subject matter expert for compliance staff in specialized tasks.
• Other responsibilities may be assigned as required.
Train and act as mentor for junior staff in the compliance team.
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