【R&D】Senior Clinical Development Associate/CDA, Development Operations Division

■ 職務内容 / Job Description

'The Clinical Development Associate (CDA) contributes to Study Delivery with appropriate quality by having primary responsibility for essential document management and coordinate tasks that improve team performance from a wider perspective during the study process. 

In addition to CDA responsibilities, Senior CDA is to

•Coordinate FTE capacity planning and monitor workload of contract CDAs.

•Lead to analyses and identifies improvement opportunities by collecting essential document QC results.

•Propose and implement risk mitigation plans and contingencies from identified essential documents quality related issue and potential issues.

•Contribute to continuous improvement activities, including study processes and other procedures.

•Mentor CDAs on internal procedures and routine activities.

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

【経験 / Experience】

＜必須 / Mandatory＞

At least 2 years’ experience in pharmaceutical industries or healthcare organization.

＜歓迎 / Nice to have＞

•Demonstrated leadership capability in a team environment successfully.
•Lead to analyses and identifies improvement opportunities.

【資格 / License】

＜必須 / Mandatory＞

Bachelor’s degree (or equivalent), preferably in biological science or discipline associated with clinical research.

【能力 / Skill-set】

＜必須 / Mandatory＞

Ability to prioritize and manage multiple tasks with conflicting deadlines.
•    Good interpersonal skills and ability to work in a team environment. 
•    Demonstrates sound knowledge of GCP and AZ procedural documents as they pertain to study delivery systems and processes.
•    Proactively identifies risks and issues and possible solutions.
•    Demonstrates analytical thinking, concern for standards, concern for impact, good team skills including cooperation, willingness to learn from others, sharing of relevant information, adaptability, self-control, tenacity, conflict resolution skills, and the ability to influence others.
•    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.
•    Consistently exhibits Leadership capability as below
▻  Works Collaboratively: shares and seeks out diverse views, incorporating them where appropriate in order to develop better proposals and creative solutions for the business.
▻   Commitment to Customers &Integrity: Tailors products/services based on an understanding of customer needs, acting with integrity to drive business value.
▻  Acts Decisively: Makes independent/effective decisions that are guided by AZ values. Speaks up respectfully and works with persistence and energy to overcome obstacles.
▻   Works Collaboratively: Creates an environment in which diverse viewpoints are sought and encouraged, both within and beyond the team (e.g. with external partners).

＜歓迎 / Nice to have＞

Consistently exhibits Leadership capability as below
▻   Commitment to Customers & Integrity; Focuses on What’s Important: Balances and prioritizes across diverse and competing customers, needs and opportunities. 
▻   Demonstrates the courage to make tough and ethical decisions about where to devote resources.
▻   Acts Decisively: Makes effective decisions despite uncertainty and/or incomplete information to drive business outcomes. Communicates clearly to ensure alignment and empowers others with decision-making authority as appropriate.

【語学 / Language】

＜必須 / Mandatory＞

日本語 Japanese：Native Level

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

【キャリアレベル / Career Level】

C/D

【勤務地 / Work Location】

Osaka or Tokyo

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 authorisation and employment eligibility verification requirements.