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PAREXEL: Quality manager, clinical data management & programming


This is a Full-time position in Hillsborough, CA posted June 12, 2020.

As Quality Manager you will primarily be responsible for supporting the Head of Clinical Data Management and Database Programming Quality Management in the following areas:Working in a global team of internal Quality Management professionals Specializing in Clinical Data Management and Database Programming, supporting Clinical TrialsDelivering the approved Quality Management System to assure management that Parexel remains in compliance with relevant procedures and regulationsKey Accountabilities:Strong partnershipsWorks closely with Operations management, other Quality functions (e.g.

Risk Management, Project Quality Leads) and with Line Manager to ensure continuous process improvement.Deputise for the Head of Clinical Data Management and Database Programming Quality Management as assigned.Audits & InspectionsRepresents Data Services QM at audits, inspections and client assessments, including preparation, conduct and follow up.Supports Operations staff at audits, client assessments or regulatory inspections, as needed.Monitors and reports on audit responses, providing metrics as appropriate.

Supports staff in use of quality systems.

Confirms close-out of assessment findings, remediation of Quality Assurance audit and regulatory inspection findings in accordance with stated response times.ConsultancyProvide Subject Matter Expertise on functional topics and Quality expectations, ensuring adequate input to SOP creation/revision.

Provides support and advice to Operational groups on the application of, and adherence to processes and the use of systems.Facilitate initiation of, root cause analysis and follow up of Quality Issues.Using process mapping and analysis techniques identify areas for efficiency gains and process improvements within Operations and Quality groups, with subsequent development and implementation of action plans.Perform Process Lead role for Partnerships and/or key accounts or provide process support to Partnerships and/or key accounts, as assigned.Key initiativesWorking with the Validation Services Group (VSG), assess technology that may include the evaluation of appropriate systems/software to increase quality and productivity.Act as the Quality representative on key initiatives as assigned.Pro-active investigationsDevelop project plans for assigned projects in line with Operations and Data Services QM strategies, based on risk.Complete or oversee the completion of assigned quality interventions/targeted/independent quality assessments/study file reviews.

Develop designated Operational group(s) specific interventions/targeted/independent quality assessments as assigned.

Feed back results and making recommendations to the Operational teams, Line Manager and Head of the Data Services QM as appropriate.Implement and oversee quality initiatives, including spot checks of risk areas, performing assessments, root cause analyses and partnering the Operational teams to facilitate the delivery of quality deliverables.QualificationsSkills: IT literate – Experience with Microsoft based applications and general knowledge of PC functions.

Able to embrace new technology and apply best practices.Culturally aware and ability to think and work globally.Ability to travel as needed for the position and to support other offices.Excellent interpersonal, verbal and written communication skills.Client focused approach to work.A flexible attitude with respect to work assignments and new learning.Willingness to work in a matrix environment and to value the importance of teamwork.Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Ability to effectively mentor less experienced members of staff.Provide leadership, direction and training to new and existing (Senior) Quality Specialists.Ability to work in partnership with Operational staff and Management, taking a lead on Quality topics.Fluent in written and oral English.Knowledge and Experience: Significant experience in one or more areas of Data Services QM (Clinical Data Management or Database Programming, supporting Clinical Trials).Understanding of Clinical technology solutions is preferred.Significant experience in a Quality/Regulatory/Quality Assurance is preferred.Understanding of GCP and clinical trial regulation.

Education: Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience.

Master’s degree in a science, technology or industry related discipline, preferred.

EEO DisclaimerParexel is an equal opportunity employer.

Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.