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Sr Quality Specialist, GCP/CRO/Pharma (Sr CRA/Clinical Lead/Trial Manager)

Company: IQVIA
Location: Portland
Posted on: November 22, 2022

Job Description:

Remote OpportunitySummary :The IQVIA QA team is a dynamic, talented, and experienced global team that owns the global quality management system for the largest human data science company in the world. The QA function is responsible for driving compliance in a highly regulated industry through audits, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research activities are of the highest quality. We proactively support our business partners and help to drive innovation. Continuous improvement is a core capability and we value strategic thinking, creativity and operational excellence. We seek highly motivated people who truly want to make a difference in the life sciences industry and are looking for opportunities to impact the business and be part of the solution. At IQVIA, we support our colleagues with a focus on succession planning, career progression and continuous learning.Purpose :This role is assigned to designated Delivery Unit(s), country/countries, sponsor(s), business units(s), and/or specific tasks as defined by the line manager (LM). Contributes to the development and is responsible for the implementation of specific quality improvement initiatives as agreed with the relevant Head(s) of assigned business lines. Provides advice and supports relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.Responsibilities:+ Adopt and implement the global Quality Management Plan within the scope of the assignment, this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.+ Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.+ Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation and delivery.+ Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.+ Work in close cooperation with teams to manage non-compliance, quality issues, assist in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs).+ Inform Quality Management, assigned business line, and Quality Assurance of quality issues according to SOPs+ Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.+ May provide assistance during audits and regulatory inspections to the teams to the extent agreed with Quality Management and as required by the applicable SOPs.+ Act as the primary contact for Quality Assurance on quality matters - on the level of the assignment , attend meetings/teleconferences+ Prepare periodic reports to Head(s) of business lines on quality related matters, risk assessments and specific quality improvement initiatives.+ Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.Required Education and Experience:+ Bachelors degree in life sciences or equivalent+ Minimum of 3-5 years' prior relevant experience; or equivalent combination of education, training, and experience.+ Fluent in English.Required Knowledge, Skills and Abilities:+ Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience.+ Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes.+ Excellent organizational, interpersonal and communication skills.+ Excellent judgement and decision-making skills.+ Demonstrated leadership and line management skills.+ Excellent influencing and negotiation skills.+ Strong computer skills including Microsoft Office applications.+ Excellent problem-solving skills.+ Demonstrated ability to work in a matrix environment.+ Ability to lead and motivate a clinical team also required.+ Ability to travel within the region/country.+ Ability to establish and maintain effective working relationships with co-workers, managers and clients.Travel:+ 10-15%IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at https://jobs.iqvia.comWe are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoeAs the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-statusNew York City Pay Transparency : The salary range for this role is $100,000 - $125,000.The actual salary will vary based on factors like candidate qualifications and competencies.EEO Minorities/Females/Protected Veterans/Disabled

Keywords: IQVIA, Portland , Sr Quality Specialist, GCP/CRO/Pharma (Sr CRA/Clinical Lead/Trial Manager), Executive , Portland, Maine

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