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
Job Description:
Responsible for ensuring quality compliance is maintained within the Interactive Technologies division during both the project development phase and the maintenance phase.
JOB FUNCTIONSIRESPONSIBILITIES
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.
SUPERVISION
Train and act as mentor for junior staff in the compliance team.
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EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Perform all assigned tasks with minimal supervision.
• Manage multiple timelines with minimal supervision.
• Write accurate and efficient SOL queries with level ranging from simple to complex.
• Possess strong verbal and written communication skills.
• liaise professionally with team members and system users.
• Solid knowledge of clinical trials is required.
• USiLATAM/CAN: Minimum of 2 years experience in a quality compliance or quality assurance role preferred. Alternatively 2 years prior experience in clinical research.
• EU/APAC: Prior relevant experience in quality compliance or quality assurance inside or outside of clinical research. Alternatively, prior relevant experience in clinical research
EDUCATION REQUIREMENTS
Bachelor's degree in information systems, science or other relevant discipline preferred
Additional Information:
Experience: Min. 2 years
Location: Chennai
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Code: 008156
End Date: 28th Feb, 2014
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