Date posted: Oct 27, 2025
City: Tokyo
Country/Region: JP
Type of Contract: Full-time Employment / Unlimited
Job Requisition ID: 10196
ICTR-Japan Clinical Operation Project Manager
Mission
For studies, ensure the set up and the progress of the clinical studies under responsibility, in accordance with local regulations, Good Clinical Practices, internal procedures, technical protocols.
Activities & Responsibilities
Support the Japanese development strategy to the Core Team/Asset Team
- Conduct, arrange and provide the documents for the PMDA consultation in collaboration with WRA/J-RA
- Perform country/centre feasibility and propose experts and investigator's centres to carry out the study (with expertise, the number of patients planned, in accordance with the protocol, respecting deadlines for recruitment, visit recovery and data queries)
Set up studies and follow-up progress:
KOL management
- Participate in the review of study documentation (protocol, CRF, …)
- Local adaptation of the scientific documents (IB, protocol, ICF, …) in accordance with the Japanese regulation.
- Coordinate financial aspects of the study (contracts with external partners, investigators associations, hospitals, …) in collaboration with the Contract and Budget Administrator (CBA)
- Define equipment needs (CRF, Therapeutic Units, …)
- Ensure scientific and technical training of the CRAs for the studies under their responsibilities
- Complete authorization files for submission to Regulatory Authorities
Verify that the study is carried out according to planned quality and scientific standards, propose and set-up any corrective actions to be taken
Respond to audit findings and set-up actions to be taken
- Organize and coordinate investigator training (investigator's meetings, …)
- Follow-up Pharmacovigilance aspects of studies under my responsibility
- Supervise the management of Therapeutic Units
- Supervise the centre closures, inform Regulatory Authorities and comply with Japanese Requirements
- Discuss contract details with the local depot and complete the contract for study
- Responsible for all management of IMPs in Japan from import to disposal for study in charge of
- Manage bills and payments from the local depot
- Collaborate with the CLS representative in study team and the local depot to import IMPs without delay and manage IMPs accurately in Japan
- Provide necessary information to the local depot and CRAs to store and transport IMPs to study centres in accordance with the Pharmacy Manual for study in charge of
- Using designated systems, manage inventory of IMPs in Japan to ensure conducting the study in charge of smoothly
Skills and Education:
Mandatory:
- Minimum of 3 year experience in Clinical project management or lead CRA
- Communication, writing and presentation skills in English (practical skills).
- Bachelor's degree in life science
- Curious and open minded
Desirable:
- Pharmacist license or medical doctor license
- Master's degree in life science
- Strong leadership
- Oncology study experience
Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.
At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.
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