Project Manager （SrMgr、Dir、SrDir） /Japan / 非公開
|職種||Project Manager （SrMgr、Dir、SrDir） /Japan|
・Project Administration Acts as a primary liaison between the Company and the Customer to ensure study launch conduct and closeout according to the Customer’s and the Company's contractual agreement. Coordinates project organization implementation and management activities between all Company operations and the client. Manages the executed contract and financial aspects of assigned projects including reviewing study budgets and expenses. Oversees and tracks site payment issues as required. Alerts Finance on the need for Customer invoicing. Oversees the regulatory document collection and submission process. Ensures project documentation including Trial Master Files are complete and audit ready. Assists in the negotiation and contracting process with outside vendors （labs printers etc）. May perform or oversee site feasibility assessments. Reviews protocol Case Report Forms and edits specifications for consistency within each document cross checking these documents against each other. Develops and maintains project plans for the study in accordance with Standard Operating Procedures （SOPs） and Work Instructions （WI）. Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status resourcing and tracking reports and functional area plan to appropriate team members and senior management. Performs ongoing review of project financial status of studies. Alerts senior management to potential issues and ensures necessary corrective action is taken.
・Communication Independently prepares and presents study material at client meetings and communicates outcomes to project team at review meetings. Attends clinical monitoring staff meetings project team meetings clinical committees and clinical training sessions according to the project communication project management monitoring and/or training plans.
・Business Development Develops strong relationships with current clients to generate new and/or add on business for the future. Supports the Business Development department by participating in Customer proposal development as well as providing information on the Company's capabilities patient populations etc. May present Company capabilities as well as project management specific responsibilities at Customer proposal defense meetings.
・Knowledge/Training ・ Demonstrates mastery of curr
|求める経験||BA/BS in the life sciences nursing degree or equivalent combination of education and experience. Moderate clinical research experience in a contract research organization （CRO） pharmaceutical or biotechnology company. Previous technical and managerial experience in conducting multi national and/or local clinical trials in a hospital setting pharmaceutical company or CRO. Some time must have been spent actively managing clinical research projects across functional areas. Thorough knowledge of regulatory requirements drug development and clinical monitoring procedures. Demonstrated proficiency with ICH/GCP guidelines. Keen insight independent judgment
and tactful discretion. Strong presentation documentation and interpersonal skills as well as a team oriented approach. Proficient computer skills in Word Excel PowerPoint email and Internet. Basic computer skills using MS Project. Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.
|年収||1000万円 - 2000万円|