Freelance GCP Auditor / GCP監査員・治験監査コンサルタント（業務委託）

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

ProPharma is expanding its network of Japan-based freelance Good Clinical Practice (GCP) auditors to support pharmaceutical, biotechnology and clinical research clients on individual assignments across Japan. We welcome established lead auditors as well as experienced co-auditors with demonstrable, hands-on GCP audit experience.

Assignments may involve clinical investigator sites, contract research organisations (CROs), outsourced trial vendors, sponsor processes or clinical trial documentation and systems. Work can be on-site, remote or a combination, depending on the client and audit scope. This is a project-based consulting opportunity, not a permanent role or a promise of continuous work.

• We are interested in auditors with proven experience in one or more of the following areas; no individual is expected to cover every audit type.
• Clinical investigator-site audits: routine/qualification, risk-based and for-cause audits; protocol conduct, informed consent, safety reporting, investigational product accountability and source records.
• CRO and vendor qualification: full-service CROs, clinical monitoring, data management, trial operations and specialist outsourced service providers.
• Sponsor and clinical quality-system audits: oversight of delegated activities, clinical QA systems, quality procedures, audit programmes, deviations and CAPA.
• Trial Master File (TMF/eTMF), essential-document and trial-record audits, including data integrity, completeness, traceability and records governance.
• Clinical technology, laboratories and service-provider interfaces: eClinical/EDC systems, central laboratories, sample handling, clinical trial pharmacies and GCLP-related activities, where within your expertise.
• Inspection readiness, mock inspections, critical issue investigations, for-cause reviews and remediation or CAPA-effectiveness assessments.

• →Plan and conduct independent, risk-based GCP audits against the agreed scope, applicable Japanese GCP requirements, ICH GCP principles, protocols and relevant sponsor procedures.
• →Review pre-audit records; prepare audit plans, interview topics and document requests; and assess clinical trial processes, controls and objective evidence.
• →Interview site or vendor personnel, review trial documentation and systems, and lead or contribute to audit opening, debrief and closing meetings.
• →Record clear, defensible observations, assess significance and potential impact on participant safety or data reliability, and prepare timely audit reports.
• →Support agreed follow-up, including review of responses, root-cause analysis and CAPA adequacy, while maintaining confidentiality, objectivity and appropriate professional independence.

• Direct experience conducting or substantively co-conducting GCP audits in clinical research, pharmaceutical, biotechnology, CRO or related settings; clinical monitoring alone is not a substitute for audit experience.
• Demonstrated capability in at least one GCP audit specialism above, including audit evidence assessment, clear finding documentation and audit-report preparation.
• Working knowledge of Japanese GCP and PMDA/MHLW expectations, with familiarity with ICH GCP and the regulatory requirements relevant to the assignment.
• Native-level Japanese proficiency for detailed interviews and review of Japanese clinical and quality documentation.
• Professional English sufficient for international coordination and audit reporting; based in Japan and able to support agreed on-site assignments, including domestic travel when needed.

• A recent, documented GCP audit log, particularly investigator-site, CRO/vendor qualification or independent lead-auditor engagements.
• For-cause or critical-issue investigator-site audits, remote CRO audits, and TMF/eTMF or sponsor oversight assessments.
• Familiarity with contemporary risk-based quality management and ICH E6(R3), as relevant to the applicable Japanese and client requirements.
• Experience with inspection readiness, PMDA/FDA/EMA inspections, CAPA assessment, clinical data systems, GCLP or specialist clinical trial vendors.
• Strong English audit-report drafting, prior independent consulting, and the ability to support international clients across time zones.

Engagements are agreed individually and may include audit planning, document review, one or more audit days, report writing and follow-up. The mix of remote and on-site work, hours, fees, deliverables, travel arrangements and reimbursable expenses is confirmed before each engagement. Appointments depend on scope fit, availability, client approval and applicable contractor onboarding. There is no guaranteed volume or frequency of work.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***