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【Janssen】R&D, Outsourcing Management Staff (Japan Clinical Operation Div.)
Requisition ID: 1805634459W
Outsourcing Management Staff ( for all external partners )
■The focus of this position is to work as counterpart to outsourcing supplier to enable the business plan, lead and implement the outsourcing model into JCO with healthy relationship with the external partners.
■Leads all outsourcing strategy and activities related to the company relationship, programs, and projects. And simplify the outsourcing models and process including the oversight process in JCO in cooperating with the key stakeholders.
■Establish the partnership models and quality plans in cooperating with global external alliance partners. And find the best methods to oversight on the external partners by developing the key performance and quality indicators.
■The focus of this position is also to manage all external service providers required by protocol in accordance with J&J policy.
■Multiple vendor support activities as CTS manager role, overseen by the incumbent include, but are not limited to, Interactive Web (Voice) Response Systems (IW(V)RS), central ECG, Medical Imaging, and Patient Reported Outcomes (PRO) scales translations & printing.
■Keep / Strengthen good communication with external partners by sharing the pipeline and having a meeting closely.
■Establish the new / innovative out sourcing model into JCO
■Manage the governance structure to oversight the external partners to maintain the high quality service, accountable for as below, but not limited to
•Ensuring KPIs for trial performance tracking are appropriately defined
•Driving trial ‘key quality indicators’ development work
•Ensuring training external partners
■Handle the resource meeting aligning to the JCO resource plan.
■Introduce CRO resources to a project smoothly and timely in alliance to JCO resourcing strategy with flexibility.
■Lead and negotiate the confliction between JCO and CRO to get to the solution fairly for each other, in cooperating with the global external alliance team as needed.
■Summarize relevant SMO information
EDUCATION, EXPERIENCE & SKILL REQUIREMENTS:
Outsourcing Management Staff’s degree (or equivalent) is required, as well as 1–2 years of relevant work experience. Although a bachelor’s degree is preferred, other relevant experience and skills may be considered by the hiring manager when considering a candidate’s eligibility. Be required strong organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Be required perform activities in a timely and accurate manner.
Good working knowledge of ICH-GCP, company standard operating procedures, local laws, and regulations.
Good organizational skills, and strong communication / negotiation skills in written and verbal
Excellent independent time management skills.
•A proven ability to plan and track deliverables and timelines.
•The individual must work well in a dynamic environment and be able to prioritize and respond to changing business needs.
•Strategic thinking beyond own function; is familiar with and takes into account overall business objectives and company strategy
•Demonstrated excellent leadership and change management skills with focus on execution and client orientation
•Flexibility and willingness to take on and lead special tasks and projects as assigned
In additionally, such as below is preferable,
•Strong experience with outsourcing trials
•Ability to multi-task and set priorities
•Strong communication skills and active listening skills with proven application with clients and internal stakeholders in a solution oriented manner
•Ability to handle and oversee multiple tasks simultaneously
•Analytical skills, quick perception and excellent judgment; able to identify risks and problems, to develop adequate problem solving strategies even in complex situations, and to take appropriate measures when required
•Business English (oral and written)
Janssen Pharmaceutical K.K. (7195)