Post for a Associate Director, Clinical Quality Assurance at ICON Clinical Research | Philadelphia / North Wales (PA), USA
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: Associate Director, Clinical Quality Assurance
· Ensuring that QA audits of clinical trial data are conducted effectively in order to assure compliance with ICON or Sponsor SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations and ISO 9000 requirements
· Ensure consistency of auditor training and reporting on a regional basis
· Recognize, exemplify and adhere to ICON's values which center on our commitment to People, Clients and Performance
· Manage the CQA group in the relevant ICON office(s), including assignment of workload, scheduling of audits, supervision of managers and auditors and review of audit results
· Train QA managers and auditors and assist in training other staff regarding GCP, ISO 9000, role of QA and regulatory audits, etc
· Ensure that all personnel are aware of the ICON requirements for quality
· Ensure that regular and random QA audits (internal and external) are conducted in order to assure that clinical studies managed by ICON are of the highest standard and are in compliance with the requirements of ICON or Sponsor SOPs, study protocols, relevant regulations and guidelines and with ISO 9000 requirements
· Ensure that audit results are formally and consistently recorded and reported and that corrective/preventive actions have been requested and documented effectively
· Liaise with clients and project managers on quality aspects of studies including the attendance at marketing meetings, project meetings, oral presentations and audits
· Proactively develop and maintain the ICON quality systems and procedures, in line with changes in laws, standards and regulations and to ensure process improvements
· Plan and co-ordinate specific projects related to the development and improvement of the ICON quality assurance clinical auditing program
· Prepare the local department budget and ensure effective cost control
· Ensure that Sponsor and Regulatory audits are effectively executed and provide support and direction during the hosting of such audits as necessary
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