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求人ID : 1445670 更新日 : 2024年04月29日
臨床開発リーダー・臨床開発プロジェクトマネージャーのご経験のある方は歓迎です。

【1500~1700万円】Associate Director Clinical Operations

採用企業 非公開
勤務地 東京都 23区
雇用形態 正社員
給与 1500万円 ~ 1700万円

募集要項

【求人No NJB2149788】
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

応募必要条件

職務経験 無し
キャリアレベル 中途経験者レベル
英語レベル 流暢
日本語レベル ネイティブ
最終学歴 大学卒: 学士号
現在のビザ 日本での就労許可が必要です

スキル・資格

■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

勤務地

  • 東京都 23区

労働条件

雇用形態 正社員
給与 1500万円 ~ 1700万円
勤務時間 09:00 ~ 17:30
休日・休暇 【有給休暇】初年度最大13日 1か月目から ※入社月により按分されます。 【休日】完全週休二日制 土 日 祝日 年末年始 ※有…
業種 CRO

職種

  • 技術・専門職系(メディカル) > 臨床開発、治験、CRA・CRC

会社概要

会社の種類 外資系企業