求人情報詳細OFFER DETAIL

Clinical Operation Manager

Line management responsibility for 5-10 Clinical Operations staff.

募集業種
Clinical Operation Manager
職務内容
・This position is responsible to manage the value/productivities of RCOJ and endure successful management of clinical trial activities/practices. ・Line management responsibility for 5-10 Clinical Operations staff. ・Work with other RCOJ line managers and head of RCOJ to support and supervise all clinical trial activities in Japan. ・Work with GCO colleagues to ensure global alignment of study progress and processes. Roles & Responsibilities ・Exceptional organizational and planning skills and independent decision-making ability. ・Anticipate resources needs and allocate resources in alignment with R&D priorities and objectives to ensure timely and accurate execution of clinical trials. ・Resource assignment in alignment with project prioritization based on skills and abilities with in the team. ・Initiate actions in response to multiple/changing demands and priorities on the team. ・Provide workload evaluations to upper management with resource assignments and task assignments for projects. ・Supervise and coordinate the work assignments and performance of their team. ・Based upon an objective evaluation of performance, reward and reinforce high performance through both monetary and creative recognition and celebration. ・Develop a strategy for building and maintaining a high performance team; recruit and selecting candidates through a disciplined selection process. ・Develop and review of metrics for operational performance of the department. ・Track and manage performance behaviors and standards. ・Conduct performance assessment procedures, e.g. objective setting and performance evaluations. ・Ensure functional excellence and career development of their team; develop personal training plans, facilitate orientation, training and mentoring programs. ・Consistently and proactively provide coaching, counseling, feedback and identify developmental opportunities for team members Perform general and human resource administrative functions. ・Create and implement succession plan for own role and key talent in team. ・Plan and lead staff meetings (identify topics for presentation, arrange speakers, coordinate the location and other amenities, etc...). ・Effectively communicate with and influence relevant stakeholders in and outside the organization. ・Participate in global and/or inter-disciplinary work groups, task forces, teams, initiatives, etc... ・Identify and implement best practices and continuous improvement. ・Act as a subject matter expert in multiple areas of clinical research and exercise sound judgement in resource allocation, budget management and staff recruitment. ・Resolve complex issues independently. ・Take a broad business perspective when making decisions. ・Build and maintain relationships with key roles in Japan and across global clinical operations. ・Influence and understand the needs of a wide range of local and global stakeholders in a heavily matrixed environment.
経験/資格
・ A minimum of 10 years pharmaceutical industry experience. ・Good understanding of the drug development process. ・Advanced knowledge of clinical operations and systems. ・An in-depth understanding of the clinical development process including regulations (local and international), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines. ・Experience in the planning, conduct and management of clinical trials. ・A minimum of 5 years study management experience. ・Strong English language capability
勤務地
東京

企業データ

会社名
非公開 まずはエントリー下さい。
設立
1960 年
資本金
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従業員数
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事業内容
医薬品の輸入、製造、販売
コメント
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  1. 有料職業紹介事業
  2. 人材育成コンサルティング事業
  3. 厚生労働大臣
  4. 許可番号 13-ユ-302907
  5. 県知事認可法人 許可番号
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