Were 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.
Officebased/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 utilization
- Oversee staff performance to ensure efficiency and productivity
- Conduct performance appraisal and foster professional development of departmental staff
- Team training and mentorship training compliance tracking
- Oversee planning conduct and reporting of field training. Perform supervised monitoring visits.
- Implement quality control participate in Risk Review Meetings and CAPA investigation meetings
- Develop and implement quality systems including quality systems documents
- Prepare for and participate in site and systems audits/ regulatory inspections
- Attend project review meetings with the local project teams. Manage crisis and resolves conflicts on project and trial site levels
- Participate in feasibility assessment projectspecific site identification and selection
- May support with Business Development tasks such as client meetings trade fairs key medical events and networking with medical communities and opinion leaders
Qualifications :
- PharmD or university degree in Life Sciences or related field
- Proven experience in clinical operations management preferably in a CRO or pharmaceutical company
- Indepth knowledge of clinical research processes GCP standards and local regulatory requirements in Japan
- Experience in team management hiring resource allocation and budget oversight
- Excellent leadership communication and interpersonal skills
- Fluency in English and Japanese
- Advanced proficiency in Microsoft Office applications
- Demonstrated ability to prioritize effectively
- Strong analytical and problemsolving 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 well be there with you every step of the way. We will guide and support you with information making your interview experience smooth and comfortable.
Remote Work :
No
Employment Type :
Fulltime