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【AstraZeneca】【R&D】Japan Clinical Operation Program Development Lead, Development Operations, Development Operations, BioPharma Clinical Operation

AstraZenecaTokyo,Japan

12 days ago

Job description

Typical Accountabilities :

As a regional technical expert develops and maintains or project manages the study management process and technology required in clinical trials
Acts as a source of knowledge in area of expertise, defining and communicating important initiatives across departments and functions
As a project manager plans and leads the delivery of all components of a clinical study to time, quality, budget, project standards, company quality standards, and scientific requirements from the study design team
As a project manager leads preparation and delivery of study documents
As an expert accountable for specialised research or delivery of internal reports to enhance the effectiveness of study management contributions to worldwide submissions across a range of products
Applies expert statistical skills to support internal proposal development and external regulatory submissions
Keeps own knowledge of best practices and new relevant developments up to date
Leads and implements globally agreed study delivery and Clinical Development strategies including process and technology related to Study Delivery

Typical People Management Responsibility (direct / indirect reports) :

Approximate number of people managed in total (all levels) - 10

Matrix Manager – (projects / dotted line)

What is the global remit? (how many countries will the role operate in?) :

Own country

Education, Qualifications, Skills and Experience :

Essential : Bachelor’s degree in relevant discipline; Significant experience in Study Management within a pharmaceutical or clinical background; Thorough knowledge of Patient Safety processes and local regulations

Desirable : Advanced degree within field; Professional certification; Clinical study delivery operational experience; Project management experience

Key Relationship to reach solutions :

Internal (to AZ or team) : Study Management function; Development function; Other AstraZeneca employees

External (to AZ) : External service providers and regulatory bodies

Date Posted

01-7月-2025

Closing Date

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Clinical Clinical • Tokyo,Japan