Clinical Compliance Operations Manager, R&D Japan - Koto City, 日本 - CSL Behring

説明

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

• Extensive understanding of the clinical research and drug development life cycle.
• 5+ years of professional work experience in a Clinical Development / GCP auditing.
• Experience in PMDA inspection preparation and management is desirable.
• Experience in a management role is desirable.
• Thorough knowledge of ICH GCP, Japan Pharmaceutical Affairs Law and GCP, FDA GCP Regulations and EU clinical trials directives.

Competencies

• Experience of working in a global pharmaceutical environment
• Experience of working in a Quality or Compliance related and / or Process Management related environment / role
• Strategic development and analytical skills
• Experience in managing processes with a continuous improvement approach
• Strong leadership and communication skills with special emphasis on collaboration, influencing and negotiation skills
• Demonstrated ability to navigate and negotiate competing priorities in a challenging environment
• Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actions
• Ability to work and collaborate at all levels within an organization
• Excellent communication and training skills, including English language skills desired
• Excellent organizational and time management skills
• Attention to detail
• Ability to work independently and as a team member
• Planning & co-ordination skills
• Diplomacy skills

Our Benefits

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About CSL Behring

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.

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