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新着求人 臨床開発  (MRI-39)
募集職種 外資製薬企業の Manager, Clinical Operation
勤務地 東京
会社概要 非公開
求人要件 To lead and manage a cross functional Clinical Operations Unit, ensuring delivery of clinical operations effectiveness in RCO
(Key Responsibilities and Major Duties)
• Supervises and coordinates the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Managers (CT Mgrs), Clinical Trial Monitors (CTMs), Clinical Trial Associates (CTAs), Site Relationship Managers, Study Start-up Specialists and/or Site Contract Leads to ensure timely execution consistent with R&D and local research goals and priorities
必要要件 【応募資格 Degree/Certification/Licensure】
Bachelors or Masters Degree within life sciences or equivalent
Experience – Responsibility and minimum number of years
• Minimum of 5 years Pharmaceutical industry experience in Clinical Research or Medical Affairs
• CT Monitor Line Manager - Prior monitoring experience required"
• Significant experience in the planning, conduct and management of clinical programs (Phase I-IV)
• Demonstrated ability to drive project related activities
• Previous supervisory and/or leadership experience (i.e. participation in task force, initiative or cross functional team)
• Previous resource allocation experience preferred
• Experience mentoring and providing feedback to others
Competencies – knowledge, skills, abilities, other
• In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs
• In depth knowledge and understanding of clinical research processes, regulations and methodology
• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
• Demonstrated organizational and planning skills and independent decision-making ability
• Strong organization and time management skills and ability to effectively manage multiple competing priorities
• Outstanding interpersonal, oral and written communication skills to influence, inform or guide others
• Good verbal and written communication skills (both in English and local language).
Software that must be used independently and without assistance
• Microsoft Suite
• Clinical Trial Management Systems
Travel Required (nature and frequency)
Domestic travel to clinical trial sites
International travel where required
年収 能力、経験を考慮の上、当社規程により優遇 
募集背景 非公開 
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