This position is responsible for the successful management of post-marketing surveillance across various therapeutic areas in partnership with global and regional teams
Job Summary
This position is responsible for the successful management of post-marketing surveillance across various therapeutic areas in partnership with global and regional teams.
The Clinical Program Manager oversees study resources, financial responsibility, and ensures compliance with Japanese regulations and GPSP standards.
Candidates must possess advanced knowledge of disease areas and full-cycle study management experience from start-up to close-out.
Matching Summary
This position is responsible for the successful management of post-marketing surveillance across various therapeutic areas in partnership with global and regional teams.
Skills & Requirements
Must-have
8+ years relevant experience
5+ years PMS experience
4+ years cross-functional project management
CRO vendor selection and oversight
Japanese regulatory compliance (GPSP)
J-PSR dossier preparation
Nice-to-have
Strong influencing and communication skills
Change management capabilities
Hands-on approach to operations
Willingness to travel as required
Subject Matter Expertise in therapeutic areas
Key Requirements
BA/BS/RN with 8+ years or MA/MS/PhD with 6+ years experience
Minimum 5 years of PMS experience in pharmaceutical companies
TOEIC score of 750 or higher
Thorough understanding of Japanese regulations and ICH guidelines