【AstraZeneca】【R&D】Study Manager, BioPharma CO, Development Operations Division

Posted 14 Days Ago
Be an Early Applicant
2 Locations
In-Office or Remote
Senior level
Biotech • Pharmaceutical
The Role
Lead and manage a clinical delivery team to operationally deliver clinical studies or project work packages in Japan, ensuring timelines, budget, quality and compliance (ICH-GCP/J-GCP). Oversee risk identification, training, meetings, stakeholder communication, and coordination across development phases and therapy areas.
Summary Generated by Built In

■ 職務内容 / Job Description

'Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in Japan R&D.
Clinical Operations is the organisational home for the operational delivery and programme and project management of clinical projects, drug and non-drug. 

■ 応募資格(経験、資格等)/ Qualification (Experience & Skill etc.)

【経験 / Experience】

<必須 / Mandatory>

  • At least 5 years’ experience from within the pharmaceutical industry or similar organization or academic experience.
  • Extensive knowledge of clinical operations, project management tools and processes
  • Understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g. ICH-GCP/J-GCP, local regulations, study management
  • Good experience of clinical development / drug development process in various phases of development and therapy areas
     

<歓迎 / Nice to have>

  • Working experiences in Clinical Development/ Quality Assurance, especially Oncology experience
  • Knowledge of process improvement methodology such as Lean Sigma/Change Management

【資格 / License】

<必須 / Mandatory>

  • Bachelor’s Degree in Science or related discipline

<歓迎 / Nice to have>

  • Medical or biological sciences or discipline associated with clinical research. 
  • Advanced degree is preferred. 

【能力 / Skill-set】

<必須 / Mandatory>

  • Excellent Communication and relationship building skills
  • Proven ability to prioritize and manage multiple tasks with conflicting deadlines
  • Excellent interpersonal skills and proven ability to facilitate team building and team work
  • Proactively identifies risks and issues and possible solutions
  • Demonstrates ability to prepare and deliver study related training materials
  • Demonstrates ability to plan, coordinate, and facilitate internal and external meetings
  • Demonstrates professionalism and mutual respect
  • Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
  • Proven learning agility
  • Basic knowledge and experience of quality management

<歓迎 / Nice to have>

  • Project management certification 
  • Ability to interact widely and effectively within the company at all levels. Good networking skills
  • In-depth knowledge of clinical and drug development process
  • Fiscal and financial awareness

【語学 / Language】

<必須 / Mandatory>

英語 English:Business English (Achieve common understanding at the context level)

日本語 : Native

【キャリアレベル / Career Level】

D

【勤務地 / Work Location】

Osaka or Tokyo

Date Posted

11-11月-2025

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Skills Required

  • At least 5 years' experience within the pharmaceutical industry or similar organization or academic experience
  • Extensive knowledge of clinical operations, project management tools and processes
  • Understanding of ICH-GCP/J-GCP, local regulations, and study management
  • Experience of clinical development / drug development process in various phases and therapy areas
  • Bachelor's degree in Science or related discipline
  • Excellent communication and relationship-building skills
  • Proven ability to prioritize and manage multiple tasks with conflicting deadlines
  • Excellent interpersonal skills and ability to facilitate team building and teamwork
  • Proactive risk and issue identification and proposing solutions
  • Ability to prepare and deliver study-related training materials
  • Ability to plan, coordinate, and facilitate internal and external meetings
  • Professionalism, mutual respect, organization, time management, attention to detail, and multi-tasking ability
  • Proven learning agility
  • Basic knowledge and experience of quality management
  • Business-level English
  • Native Japanese
  • Working experience in Clinical Development or Quality Assurance, especially Oncology
  • Knowledge of process improvement methodology such as Lean Sigma/Change Management
  • Medical or biological sciences background or advanced degree
  • Project management certification
  • Ability to interact widely within the company and strong networking skills
  • In-depth knowledge of clinical and drug development process
  • Fiscal and financial awareness

AstraZeneca Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AstraZeneca and has not been reviewed or approved by AstraZeneca.

  • Fair & Transparent Compensation Pay is considered competitive across many roles when total rewards are factored in. Senior scientific and leadership bands are described with high ranges that reinforce competitiveness at upper levels.
  • Strong & Reliable Incentives Bonuses, equity eligibility in many salaried roles, and solid sales on‑target earnings with upside are emphasized as meaningful parts of compensation. These elements boost overall value even where base pay is not the very highest.
  • Retirement Support A 401(k) program with a strong company match and immediate vesting is repeatedly cited as a standout. Generous retirement support is viewed as enhancing the total package relative to peers.

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The Company
HQ: Gaithersburg, MD
70,000 Employees
Year Founded: 1999

What We Do

We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet.

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