Head of Site and Study Management

Company Overview
Pharmaceuticals Company

Job Description
1. Directly manages and develops staff of approximately 10 staff (including Study Managers, Country Lead Monitors, Study Lead Monitors, CRAs). Assures hiring insourced CRAs, training, coaching, personal development, appraisal and promotion are in line with talent
and job expectations. Also assures that CRAs are assigned to fully monitor and manage all site related activities and data to provide necessary quality and data required for global and local regulatory submissions and approval of drugs. Through effective management and development of direct reports, the SSM Group Line Manager ensures quality and compliance as well as ensuring GD Japan and study objectives are met. Provides expertise and strong leadership and management to direct reports and maintains a motivated and competent staff.
2. Manages and coordinates the strategic and operational harmonization of international/multi-national clinical trials. Assures that information obtained from source documents is accurate and complete and that the results of clinical studies performed can be used for global and local registration dossiers. Tracks study progress, patient enrollment and monitoring progress to meet Study Plan, protocol and Monitoring Plan deadlines and manages all activities of the StM to ensure appropriate study execution and all activities of the Monitor to ensure timely collection, review, and correction of data in accordance with the quality standards.

Requirements
■At least 12 years of clinical operation experience as well as Line Management experience
■Extensive experience in the pharmaceutical industry / pharmaceutical product development experience
■In-depth knowledge of clinical development and drug development process, ICH-GCP, applicable legal, compliance and regulatory requirements.
■Native Level Japanese, English TOEIC 730 or above
■Leadership, motivational, and interpersonal skills are critical.
■Incumbent must possess the ability to lead staff in changing times as well as strong interpersonal skills in the management and development of people in a global environment.
■Administrative, financial, and technical skills are required

日本東京 地図

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