Company Description

PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

In an industry where cost-cutting and layoffs are common, PSI stands out as a stable and secure workplace. Our dedication to stability is evident in our exceptionally high repeat and referral business rate and minimal staff turnover. Many of our colleagues have been with us for over 15 years, contributing to our long-standing traditions and history. Our expansion into Japan continues this legacy, and we seek team members who will grow with us for the long term.

Job Description

We're on the lookout for a highly skilled and experienced Clinical Operations Manager to join our team in Tokyo, Japan. As a key member of PSI Japan, you will lead and develop our Clinical Operations team in Japan, help to establish our operational presence in the country, and enjoy all aspects of operational & strategic management.

Office-based/Hybrid in Tokyo

You will: 

Line manage assigned staff (CRAs and SMAs)Manage resource allocation to projects and resolution of resourcing conflicts, resource workload and utilizationOversee staff performance to ensure efficiency and productivityConduct performance appraisal and foster professional development of departmental staffTeam training and mentorship, training compliance trackingOversee planning, conduct and reporting of field training. Perform supervised monitoring visits. Implement quality control, participate in Risk Review Meetings and CAPA investigation meetingsDevelop and implement quality systems, including quality systems documentsPrepare for and participate in site and systems audits/ regulatory inspectionsAttend project review meetings with the local project teams. Manage crisis and resolves conflicts on project and trial site levelsParticipate in feasibility assessment, project-specific site identification and selectionMay support with Business Development tasks such as client meetings, trade fairs, key medical events and networking with medical communities and opinion leaders

QualificationsPharmD or university degree in Life Sciences or related fieldProven experience in clinical operations management, preferably in a CRO or pharmaceutical companyIn-depth knowledge of clinical research processes, GCP standards, and local regulatory requirements in JapanExperience in team management, hiring, resource allocation, and budget oversightExcellent leadership, communication, and interpersonal skillsFluency in English and JapaneseAdvanced proficiency in Microsoft Office applicationsDemonstrated ability to prioritize effectivelyStrong analytical and problem-solving skills

Additional Information

Make the right call and take your career to a whole new level, where quality is the cornerstone of your work and training.  If shortlisted for an interview, our recruitment process is easy and straightforward, and we’ll be there with you every step of the way.  We will guide and support you with information, making your interview experience smooth and comfortable.