メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

Supports Senior Director to build Japan organization and required process such as Local SOP and WI.
Conducts Country level feasibility.
Supports country activity for new studies until reginal/ country COM is identified.
Supports Senior Director for vendor management for FSP partner/ Full Outsourcing in Japan.
Oversees FSP studies performance in Japan.
Conducts Site Motivation visits and Study Oversight Visits for all studies in Japan.
Prepares and supports PMDA inspection
Other tasks, if needed.

Purpose of Job in APAC:
Leads all aspects of assigned clinical trial(s) and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities
Leads matrix, multi-disciplinary, cross-functional study execution teams from start-up through to closeout to ensure both internal and external deliverables are on time and on budget working under the guidance and direction of the Clinical Program Lead.

■休日：完全週休二日制, 年末年始

Fluent in English
Excellent organizational skills and ability to prioritize and multi-task
5 years or above of progressive experience in clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field
Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required
Management experience of CROs and other Vendors preferred
Experience developing trial plans including project plan, site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required.

■職種未経験者：不可