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Manager, Clinical Compliance (WW – Quality Systems Leader)
Clinical Trial Administration
Requisition ID: 6538180320
The Medical Device Group Clinical R&D COE (Center of Excellence), a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Clinical Compliance (WW – Quality Systems Leader), located in Irvine, CA.
Under the supervision of the WW Clinical Quality Control and US Resource Management Director, this position is responsible for the following:
- Ensure clinical quality, process improvements and procedures (SOP) management and associated training management.
- Direct reports, contractors, and functional sources contracting, training, and performance.
- Develop Quality Control Plans and oversee/perform implementation of quality control activities for assigned projects according to committed timelines.
- Conduct Quality Control activities which include, but are not limited to the following:
- Quality reviews of clinical trial protocols and associated documentation (including, but not limited to Patient Information Letters, Informed Consent Documents, Patient Questionnaires, CRFs, etc.), as appropriate, to ensure compliance with relevant standards/regulations.
- Review of Trial Master File to ensure accuracy and completeness of the documentation.
- Independently perform and/or oversee the implementation of integrated and comprehensive data-driven QC activities to ensure compliance with regulatory requirements and SOPs and to ensure a continued state of inspection readiness.
- Take a lead role within Clinical R&D COE in preparation, conduct and response to internal and external audits/inspections.
- Prepare periodic quality control reports for assigned clinical projects, identify areas of risk and review and communicate trends with Clinical Trial Core teams.
- Summarize Quality Control activities, trends and areas of potential risk to Clinical R&D Leadership.
- Maintain and update Clinical R&D SOPs, Work Instructions and Policy Documents to ensure they are in alignment with relevant standards/policies/regulations/directives.
- Using available systems tools (e.g., EDC, CTMS and eTMF generated dashboards and reports), compile monthly project performance metrics for department by organizing, analyzing, preparing presentation, and facilitating Clinical Management Review (CMR) meeting.
- Identify problems through analysis of project performance metrics and recommend corrective and preventive action (CAPA) based on knowledge of applicable regulations; ensure completion of CAPAs generated through internal and external audits.
- Support Clinical R&D COE CAPA resolution by taking ownership, when applicable, on the corrective and preventative actions; track and ensure timely resolution of all Clinical R&D CAPAs.
- Actively engage and collaborate with Clinical Trial Managers/Leaders and other members of the Clinical R&D COE, as applicable, to resolve any identified issues/problems.
- Participate in FDA BIMO audit preparation and execution.
- Support the implementation of new clinical systems/processes.
- Responsible for managing training curriculum for all Clinical R&D COE associates, working with the relevant associates across the campus sites to ensure compliance with all training requirements
- Participate in Clinical Trial/Study Core Team meetings, as required.
- Provide internal communication of important clinical data and events.
- Establish themselves as a reliable, trusted resource of accurate, up-to-date process knowledge as requested by key stakeholders.
- Collaborate with functional groups including, but not limited to BRQC and complaint handling groups to ensure Clinical R&D Operations adherence to company policies and regulations.
- Participate in departmental initiatives across the Clinical R&D COE aimed at improving process and efficiency, in particular for the improvement of local processes.
- Participate in project management meetings and provide an overview of clinical quality and workload as needed.
- General serves as the GCP Subject Matter Expert, for Clinical Project Teams.
- Ensures that clinical trials are conducted in compliance with all applicable GCP Regulations and Guidelines. Ensures that internal processes and procedures meet the requirements of GCP.
- A minimum of a Bachelors’ Degree is required¸ preferably in a Scientific or Technical Discipline.
- A minimum of 8 years of experience in Quality Assurance in the Medical Device Regulated industry is required. A minimum of 3 years in the R&D/Clinical Trials environment is required.
- A minimum of 2 years supervisory experience is preferred.
- A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required.
- Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
- Strategic & tactical Clinical and Business knowledge to guide the organization in regulatory inspections is required. Strong communication, organizational and interpersonal skills.
- Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, laboratories, etc.) is an asset. Ability to effectively negotiate and influence upper management, affiliates and Regulatory Agencies to ensure that regulatory and business needs are met. Ability to manage and influence external service providers.
- A minimum of 2 years of Clinical Quality Control/Assurance experience is required, Medical Device and Pharma and/or CRO monitoring experience is preferred.
- This position has 20% domestic travel with possibility for international travel and will be based in Irvine, California.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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