Manager, Data Services Quality Management

Parexel, Sheffield are recruiting for a Data Services & Quality Management, Manager. This is a great opportunity to use extensive Line Management and Data Management experience on projects to influence our Data Services & Quality Management Department.

Job Purpose:

Primarily responsible for supporting the Head of Data Services Project Quality and Risk Management:

Line Manager of a global team of Clinical Data Management and Database Programming Quality Management professionals Specialising in Clinical Data Management and Database Programming, supporting Clinical Trials Developing and delivering the approved Quality Management System to assure management that Parexel remains in compliance with relevant procedures and regulations.

Key Accountabilities:

Strong partnerships

Establish and maintain strong partnerships with Operations management, other Quality and business functions (e.g. Risk Management, Project Quality Leads) and with Line Manager to ensure continuous improvement and regulatory compliance . Promote/champion the Quality Management System within both the group and the Operational teams via Operations management. Represent Data Services PQRM at management meetings, both within Parexel Quality, Operations, and externally where assigned.

Audits & Inspections

Assigns team members to support audits and inspections as required, ensuring appropriate input is provided. Represents Data Services QM at audits, inspections and client assessments, including preparation, conduct and follow up. Supports Operations staff and team, during at audits, inspections and client assessments, 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.

Consultancy

Provide Subject Matter Expertise on functional topics and Quality expectations, ensuring adequate input to SOP creation/revision. Act as a consultant to Operations on matters pertaining to the QMS and applicable regulations. Identify continuous improvement opportunities, lead the development of recommendations and champion implementation. 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 Pro-active investigations

Develop project plans for the team and 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 DM/Programming applications/languages. G eneral knowledge of PC functions. Able to embrace new technology and apply best practices. A high level of c ultural aware ness with 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 manage and 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. Ability to work independently and take initiative to meet or exceed the team goals.

Knowledge and Experience:

Significant industry 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.