Cliniical Operation Manager / 外資製薬メーカー
|職種||Cliniical Operation Manager|
・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 b
|求める経験||・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.
・Leadership experience (i.e. participation in task force， initiative or cross functional team); experience mentoring and providing constructive feedback to others.
・A good understanding of leadership styles.
・Strong performance in management and strategic thinking skills.
|年収||1100万円 - 1400万円|