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

People Responsibilities:
•Supervision of Clin Ops managers
•Responsible for the supervision of assigned direct reports
•Responsible for detailed performance review and management of assigned direct reports including: Annual Performance Management and Development (PMD), Individual Development Plan (IDP), Line of Sight Goals and “Shoves & Tugs”
•Responsible for appropriate management and resolution of performance issues
•Measure performance indicators for assigned staff within Clinical Operations.
•Identify individual training needs and assist in the conduct of training and development efforts, regionally
•Conduct on-site Accompanied Field Visit activities (Evaluation and Quality Control Visits) for Clinical Operations staff
•Effectively communicate management strategies, policies and procedures in conjunction with leadership teams
•Develop and maintain effective relationships with management team to manage Clinical Operations staff in a matrix environment.
•Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.

Indicate the number of:
Direct Reports: Between 10 and 20 Clinical Operations Staff dependent upon business need
Indirect Reports: None

GCP Oversight Accountability
•Has GCP oversight of direct reports by ensuring GCP training is executed, understood and implemented.
•Identify and escalate GCP issues identified through regular interactions with direct reports and conduct of Accompanied Field Visits
•Ensures training record compliance with training matrix and ensures training records are up to date
•Provide input to relevant SOPs and standard plans/templates for use by Project Management and Clinical Operations staff.
•Assist with on-boarding of new direct reports ensuring GCP training before monitoring begins
•Hold Clinical Operations staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate.
•Hold Clinical Operations staff accountable for compliance with project plan and adherence to contract obligations in Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables
•Coach Clinical Operations staff to own effective Investigator relations and Investigator oversight at the local level.

Productivity/Financial Management
•Communicate status of assigned workload for metric reporting
•Perform weekly review of direct report billable hours and associated utilization per the quarterly and annual budget plan, and escalation of outliers to management team for mitigation
•Escalates available workload hours, in context of project allocation, supply and demand, to management team
•Adheres to global tools for monitoring and utilization forecasting
•Engage in Resource management activities for direct reports
•Assist with staff recruitment through screening and interviewing
•Financial authority in accordance with current signature approval matrix
•Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports
•Liaise with internal and external customers in relevant process improvement initiatives, including Six Sigma
•Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity
•Schedule Accompanied Field Visits to ensure costs are in alignment with region

■休日：完全週休二日制, 祝日, 年末年始, 土, 日

■Education/Qualifications
- 学士資格（薬学、医学、生物科学、看護などの分野尚可）
- GCP(Good Clinical Practice) の知識と関連する指導経験
- ビジネス上級レベルの英語、日本語スキル(読み書き、会話)

■Experience
- 15年以上の医薬品臨床開発の知識と経験 (モニタリング、プロジェクトマネジメント)
- クライアントとの直接のやり取りを含むプロジェクトマネジメント経
- ラインマネージャーとしての職務経験

■職種未経験者：不可