Job DescriptionThis role will report to the regional head office of the global clinical compliance leadership team under Global Clinical Operations, based in Japan.
In partnership with the Regional Clinical Operations and Global Quality,
- Support the regional study teams and sites to assure inspection and audit readiness at all times.
- Lead the implementation of the Quality Audit Plans with on-site support prior to, and during internal audits.
- Coordinate site and sponsor inspections by Health Authorities as necessary.
- In partnership with the Regional Clinical Operations teams, provide appropriate continued oversight to study teams.
- Work closely with the Clinical Quality and Risk Management team and help implement elements of the Quality Management System: identify emerging and significant risks, provide support for root cause analyses and mitigation strategies, ensure documentation and appropriately notify/escalate to the right level of Governance.
- Provide CAPA leadership by coordinating CAPA development and approval, as well as implementation and tracking of effectiveness.
- Partner with the Clinical Training, Process and Continuous Improvement organization to identify gaps/needs in training at the regional level, and providing local training support/coordination as needed.
- As the scope of Global Clinical Operations includes registrational and non registrational data generation (NRDG), regional clinical compliance activities will span across Phase I through IV studies including Investigator-Sponsored Research and Real World Data Generation. In that context, partner with GCO NRDG teams to enhance GCP compliance for NRDG in partnership with Regional/Country Medical.
- Work with management and Global Quality to foster a regional, cross functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset.
RequirementsA minimum of a Bachelor's Degree or equivalent is required. A degree in Life Sciences or equivalent is preferred. At least 5 years of experience in clinical trial operations and/or Good Clinical Practice is required. Fluency in a second language relevant to the geographical scope is a plus.
Good understanding of the drug development process and clinical operations, experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions.
Experience in matrix management and training is desirable with the ability to engage and inspire others. Good communication skills with a proven ability to effectively engage and manage key internal stakeholders (in various functions and geographies) as well as external stakeholders (including Health Authorities). Good presentation and negotiation skills with the ability to timely resolve conflict in a constructive manner.
Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills.
- Rich GCP related experience
- English（MUST) Grade: D6-D7 depending on candidate qualifications and experience
- Speed / Agility / Flexible thinker