PURPOSE
Quality Reviewer
RESPONSIBILITIES
Conduct internal Data Management Quality Reviews in order to fulfil business unit, customer and regulatory authority requirements and expectations.
Ensure that re-occurring findings/errors are communicated effectively with operational team.
Participate in review of corrective/preventative actions.
Assure recording of an appropriate response to any non-compliance, with corrective action and a timeframe for completion.
Oversee the documentation and reporting quality/compliance issues, relating to the product, process or quality system, to Management within specified regional timelines.
Collect and report quality metrics as required to Management.
Maintain working knowledge of current applicable regulatory and Sponsor guidelines and related review techniques.
Reviews aggregated information provided on the QRP and performs analysis and identification of trends on portfolio level.
Reviews the error rate on study level and contact study teams where applicable to discuss CAPA.
Liaise with Training Team to update training where needed.
Independently bring solutions to the Quality Management Team
Provide comprehensive quality review expertise
Mentor junior Quality Review Staff
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Medical terminology exposure
Excellent organizational, communication, leadership and computer skills Ability to exercise excellent attention to detail
Ability to act independently and with initiative required to resolving problems Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree, or educational equivalence, in clinical, biological or mathematical sciences, or related field, or nursing qualification with 5 years’ experience in clinical trials within a similar function, including proven competence in managing delivery of multiple projects simultaneously through full data management study life-cycle, including large trials >1000 patients; and including experience in handling customer negotiations (e.g. bid defence meetings); or equivalent combination of education, training and experience.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.