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
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.
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.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring
-
Tokyo CSL Full timePosition 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 align ...
-
Tokyo AstraZeneca Full timeDescription · Lead, Japan Clinical Operation Program (JPD, Lead) is accountable/responsible for leading the project planning for clinical operation in Japan R&D. The span of activities is broad covering clinical activities in both early and late drug development, registration/su ...
-
Tokyo AstraZeneca Full timeDescription · Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in Japan R&D. · Clinical Operations is the org ...
-
Tokyo AstraZeneca Full timeDescription · Associate Director Clinical Quality Management (ADCQM), as an ad-hoc member of Japan Clinical Quality Management Leadership Team (CQMLT), is responsible for proactive contribution to CQM organization development and capability build. ADCQM is individual contributor ...
-
Tokyo AstraZeneca Full timeDescription · 'Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in Japan R&D. · Clinical Operations is the or ...
-
Tokyo AstraZeneca Full timeDescription · Safety Process Group is responsible for: · ・Deliver training to the members who are responsible for collecting safety information (e.g. sales reps, CRAs, CROs) · ・ Support creation of safety information exchange/collection process with relevant parties to facilita ...
-
Koto City CSL Behring Full timeJob Purpose · The Ethics & Compliance Officer Japan & South Korea is responsible for implementing strategic goals, planning efforts, managing projects and providing measurable inputs into processes, standards and operational plans for the Ethics & Compliance function for CSL Behr ...
-
Koto City CSL Behring Full timeThe Biostatistician in Japan provides statistical contribution to a clinical development program, including e-data and CDISC for submission to PMDA. The Biostatistician implements statistical strategies for clinical trials and regulatory submissions, and is accountable for statis ...
-
Koto City Renesas Electronics Full time· Job Description · As the Senior Director of Regional Human Resources for Japan, you will play a pivotal role in implementing HR strategy in Japan region and driving initiatives that align with our business objectives. Reporting directly to the VP of Regional HR, you will lead ...
-
Koto City Renesas Electronics Full timeJob Description · As the Senior Director of Regional Human Resources for Japan, you will play a pivotal role in implementing HR strategy in Japan region and driving initiatives that align with our business objectives. Reporting directly to the VP of Regional HR, you will lead a t ...
-
Logistic Operator
8時間前
Koto Cencora Full timeOur team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join ...
-
Logistic Operator
8時間前
Koto City Cencora Full timeOur team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join ...
-
Koto City Danaher Full timeAt Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved ...
-
Koto City Renesas Electronics Full time· Job Description · As a member of the REL HR team reporting to the Head of Talent Acquisition Japan, you will partner with various stakeholders to build a long term, best-in-class TA function. The successful candidate will bring a proven track record of leading recruiting teams ...
-
Koto-Ku Danaher Full timeAt Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved ...
-
General Manager
6日前
Ginza MLA JAPAN Full timeRequirements · English: Fluent · Japanese: Native level · Must currently reside in Japan · Description · General Manager (Second Hand Watches wholesale) · Highly Reputable Multinational Watch Company seeks an experienced and driven General Manager to lead our team and oversee al ...
-
Chiyoda Lenovo Full timeDescription and Requirements · Modem/RF Technical Account Manager is responsible for interfacing Japanese carriers (MO and/or MVNO) to understand their modem and RF related requirements, articulate & communicate them to internal organization (Motorola R&D, product operation, sal ...
-
Legal, Ethics
7日前
Chiyoda Novo Nordisk A/SDo you want to be part of a high-performing team in one of the world's leading pharmaceutical companies? Would you like to become a business partner in our growing businesses? Then, this is your moment as we are looking for a Legal, Ethics & Compliance Counsel to join our team in ...
-
Veeva Systems
1週間前
Japan timesjobs Full time· Position: General Manager - Japan Commercial · Location: Tokyo, Japan · Department: Commercial Japan · Type: Full-Time · Work Setting: On-site · Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to pat ...
-
Chiyoda Lenovo Full timeDescription and Requirements · Position Description: · SW Technical Account Manager is responsible for interfacing Japanese carriers (MO and/or MVNO) to understand their Software and network related requirements, articulate & communicate them to internal organization (Motorola ...
