Position Purpose:
The Clinical Compliance Operations (CCO) Manager is a position within Clinical Development Operations, R&D Japan responsible for supporting the Clinical Research & Development, Clinical Operations Tokyo and Project Management to provide therapeutically aligned compliance support to study teams focusing on adherence to procedural / regulatory requirements and Corrective and Preventive Action (CAPA) coordination to ensure inspection readiness.
Reporting Relationships:
This position reports to the Senior CCO Manager and will have global responsibilities in the following location: Tokyo
Main Responsibilities and Accountabilities:
1) Provide compliance support, including quality and compliance advice / consultation, to the study programs conducted in Japan to ensure adherence with procedural / regulatory requirements and driving inspection readiness.
2) Manage Inspection Preparation activities for PMDA regulatory inspections and collaborate with Clinical Quality Assurance (CQA) to prepare internal staff. Support CQA during the regulatory inspection process to provide expertise regarding the Clinical Development quality management system.
3) Facilitate discussion on Risk-based Quality Management (RBQM) strategy and implement an effective Quality Risk Management Plan at the study level.
4) Support individual CAPAs, as appropriate, to ensure issues / deviations are thoroughly evaluated (including a risk assessment, root cause analysis and effectiveness measures) and identified actions are addressed in a timely manner.
5) Support the Senior CCO Manager in reporting metrics, identifying trends, and evaluating the effectiveness of completed CAPAs to drive continuous improvement.
6) Support the development of procedural documents (SOPs) to ensure regulatory compliance and consistency across Clinical Operations activities.
7) Manage SOP Training Completeness in Japanese Clinical Development according to the Japan SOP training matrix.
8) Support the Compensation Payment process to ensure Japanese regulatory compliance and subject’s welfare.
9) Provide GCP training to Japan clinical personnel as appropriate with support from Global CCO.
Position Qualifications and Experience Requirements:
Education
Degree (BSc / MSc / Diploma) in scientific/medical/pharmaceutical discipline is essential, preferably combined with relevant clinical trial experience and / or relevant GCP auditing experience.
Experience
Competencies
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.