Clinical Quality Operations Manager- FSP

Clinical Quality Operations Manager

Parexel FSP is excited to announce a remote opportunity for a Clinical Quality Operations Manager. This position is responsible for the execution of operational quality activities within the assigned therapeutic area. The Clinical Quality Operations Manager will oversee headquarters clinical quality operations and support clinical trial teams to proactively embed quality into client sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The CQOM will be responsible for the development of Quality Plans to implement Quality by Design within clinical development programs, using a risk-based approach. The CQOM will also be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, managing, and following up on regulatory inspections.

Primary Duties :

• Operational Quality Management : Develop Risk Assessment and Categorization Tools (RACT) and Quality Plans in partnership with the Clinical Trial Team (CTT). Perform a Therapeutic Area (TA) level review of quality plans and risk mitigation approaches to identify any emerging signals or trends and provide relevant feedback to the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations (CQO) as appropriate within a specific therapy area. Ensure comprehensive oversight of all activities delegated to third parties. Facilitate and monitor CTT oversight of vendors. Develop, review, and revise quality agreements with business partners. Ensure that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations. Facilitate and oversee the responses to audit and inspection observations as appropriate. Work with peers to analyze data across therapy areas to identify signals and trends and develop and implement appropriate process improvement strategies. Develop and maintain a profound understanding of Good Clinical Practice (GCP) with respect to digital data management. Build and enable effective working relationships with key stakeholders to ensure role clarity and business effectiveness. Contribute to the standardization of Clinical Quality Operations procedures, tools, and templates to ensure consistency and seamless progression through the study lifecycle.
• Inspection Preparation and Management : Maintain current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide. Maintain appropriate levels of knowledge and skill to effectively lead and support GCP inspections, worldwide. Collaborate with other therapeutically aligned CQOM to provide comprehensive oversight of the TA. Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). Contribute to the development and / or revision of Client policies, SOPs, and training materials. Develop the strategy for management / support for GCP inspections of Client products to ensure that all phases of Regulatory Health Authority inspections are handled consistently, professionally, and proactively and result in outcomes that demonstrate the Company's commitment to regulatory compliance. Ensure that a cross-functional team is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide. Maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses, and Corrective and Preventive Actions (CAPAs) worldwide. Act as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management in order to provide real-time, proactive advice and guidance. Escalate potentially significant inspection findings / compliance risks / impact to Client Senior Management. Develop the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.
• CAPA Management Support : Ensure that all actions and commitments related to audits and inspections are implemented in a timely manner. Tracks all inspection CAPA and regulatory commitments and checks evidence of completion. Ensure repository of evidence in Documentum is complete for all Regulatory Health Authority inspections. Provide guidance and support for Clinical Country Quality Managers regarding inspections at a country level sites that require a Client headquarters input.

Skills and Education :

EEO Disclaimer Parexel 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.