About the Role

　　Role Purpose

　　Clinical study and MAP operation role will work with multi-TA Medical department to execute clinical research studies through Contract Research Organizations (CROs) and will also lead MAP operation. The Clinical study and MAP operation role is the primary point of contact for

　　the operational execution of the study and is accountable for study delivery through oversight of

　　the chosen CRO(s) and interface.

　　Major Accountabilities

　　• Lead all below tasks on behalf of senior lead

　　• Acting as the primary point of contact for the operational execution of assigned primary

　　data collection Medical Study.

　　• Delivery of study through oversight of chosen CRO(s)

　　• Oversight of day-to-day operational activities of clinical study projects.

　　• Ownership of study risk management plan including timely communication of study

　　progress, risks and risk mitigation strategy to Program Leadership.

　　• Tracking study progress against the study schedule as detailed in Medical Study Plans.

　　• Perform job functions in accordance with all applicable Standard Operating Procedures

　　(SOP), local laws and regulations, and departmental processes.

　　• Optimize clinical operation process balancing speed, quality and resource utilization

　　• Medical study document management

　　• Execute MAP operation

　　Diversity & Inclusion / EEO

　　We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

　　Role Requirements

　　Education:

　　• Bachelor's degree

　　Languages:

　　• Japanese, Intermediary English

　　Experience/Professional requirement:

　　• Operational and managerial experience in planning, executing of

　　PDC medical study/clinical trials

　　Competency • Established knowledge of GCP, Clinical Trial Act, Ethical guidelines

　　for clinical studies.

　　• Strong cross-functional leadership skill

　　• Superior interpersonal, communication, negotiation skill

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　　• Project management skill

　　• Experienced more than one role in clinical studies (for example: CRA and Project Manager etc)

　　Division

　　International

　　Business Unit

　　Japan IMI

　　Location

　　Japan

　　Site

　　Tokyo

　　Company / Legal Entity

　　Novartis Pharma K.K.

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No