Clinical Trial Supplies Manager　※関西窓口

募集要項

• こだわり条件

  設立50年以上 語学（英語）を生かす 年間休日120日以上 土日祝日休み

• 仕事内容

  【JOB SUMMARY】
  The position provides customer focused leadership in managing operational and financial aspects of clinical trial supplies management during the complete project life cycle. Duties may include liaising with Customers vendors and/or investigative sites to manage Clinical Trial Supplies deliverables.
  Assignments may range in size and scope from single service to full scope and may include multiple studies. Accountable for successful execution of all assigned services where success includes on time on budget high quality/compliant deliverables that lead to satisfied customers.
  
  【JOB RESPONSIBILITIES]】
  Project Leadership and Delivery:
  ・Manages logistics of clinical trial supplies for assigned studies as an independent Clinical Trial Supplies Manager （CTSM）; ensures compliance with Good Manufacturing Practices （GMP） Good Clinical Practices （GCP） relevant standard operating procedures （SOPs） and regulatory requirements
  ・Ensure operational delivery and financial performance of services assigned to the CTSM team
  ・Identifies clinical trial supply vendors; manages contracting of preferred vendors as required
  ・Provides vendor management inclusive of ensuring key Clinical Trial Supplies deliverables are met
  and financial parameters of contracts are upheld
  ・Defines supplies requirements in collaboration with client packaging and distribution vendors and the PL
  ・Works with the PL to obtain parameters and inputs to implement and maintain drug and supply distribution plans
  ・Directs activities of assigned Clinical Trial Supplies Associates （CTSAs）; ensures proper resource levels to deliver work
  
  Reporting and Communication:
  ・Accountable for maintenance of project information on a variety of databases and systems
  ・Oversees the inventory supply and re supply plans for subject kits and/or study medication required for the duration of a study and provides relevant reports for customers and management
  ・Develops and implements project plans in accordance with Cont…

• 職種分類

  素材・化学・食品・メディカル系技術者 ＞ 医療・医薬・メディカル系技術者 ＞ 研究・開発（医療・医薬・メディカル）

• 業種分類

  医薬・バイオ

• 応募条件

  ・Bachelor’s Degree （or equivalent） level of qualification in Life Sciences Medicine Pharmacy Nursing or related field equivalent
  ・Prior experience in a contract research organization （CRO） pharmaceutical or biotechnology company in project management or clinical trial supplies management
  ・ Strong knowledge of Good Clinical Practice ICH guidelines Good Manufacturing Practices and other applicable regulatory requirements
  ・Strong organizational skills
  ・Strong ability to manage time and work independently
  ・Excellent communication presentation interpersonal skills both written and spoken with an ability to inform influence convince and persuade
  ・Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment
  ・High level of competency in English language
  ・Proficiency with MS Office Applications
  ・Ability to travel as necessary （up to 25%）

• 年収

  950万円～1300万円
  950万円 - 1300万円

• ポジション

  メンバー

• 雇用形態

  正社員

• 勤務地

  東京都 / 大阪府

• 勤務時間

  09:00 ～ 18:00

• 休日・休暇

  【有給休暇】15
  【休日】完全週休二日制
  年末年始
  特別休暇、疾病休暇（5日）※有給休暇・疾病休暇日数は入社月によって異なります。詳細はオファー時に通知します。

• 福利厚生

  【通勤手当】全額支給 （最大月10万円）、新幹線・特急支給対象外
  【社会保険】健康保険
  厚生年金
  雇用保険
  労災保険
  

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