347268BR
Jun 16, 2022
Japan

Job Description

9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.

DM(データマネジメント)は、製薬会社が保有する臨床データを管理する仕事です。
データベース設計、症例報告書のデザイン、臨床データの入力・クリーニング作業、臨床データ管理ツールの企画、維持、管理などを行い、収集した臨床データの品質保証と信頼性確保に努めます。
統計解析は、DMが収集・整備した臨床データの有効性と安全性をもとに、解析と臨床試験の計画策定を行う仕事です。集められた臨床データを解析できる状態に加工し、部門内だけでなく部門外との情報共有を行います。また、解析データの作成やデータ解析ツールの企画、維持、管理を行うとともに、臨床試験の実施計画を統計学的なアプローチから決定し、効率的な新薬開発をサポートします

Major Activities:
1. Provides DM leadership across assigned trial(s) Acts as the Trial Data Manager where needed

2. Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes.

3. Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards

4. Performs DM activities for start up of a study including preparing the eCRF, CCG’s where needed, Data Handling plan (DHP), Data Review Plan (DRP) and performing user acceptance testing (UAT)

5. Manage local lab set up for the Clinical Database as applicable

6. Performs DM hands on activities during the course of the study

7. Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)

8. Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation

9. Supports and assists Junior staff for assigned trials

10. Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner

11. Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence

12. Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks).

13. Ensures adherence to regulatory requirements(ex., GCP), DM standards, SOPs/WPS and process guidelines



Why consider Novartis?

817million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。
約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。
ノバルティスファーマ株式会社は、スイス・バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。https://www.novartis.co.jp

Diversity & Inclusion / EEO

ノバルティスは、優れた包括的な職場環境と、私たちがサービスを提供する患者さんや地域社会を代表する多様なチームの構築に取り組んでいます。

Minimum Requirements

Education (minimum/desirable):
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.

Languages:
Fluent English (oral and written).

Experience/Professional requirement:
1. Ability to work under pressure demonstrating agility through effective and innovative team leadership
2. Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders
3. Excellent problem solving skills
4. Ideally 4 years’ experience in Drug Development with at least 3 years' in Clinical Data Management
5. Excellent verbal and written skills
Global Drug Development
GDO GDD
Japan
東京
フルタイム
正社員
いいえ
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347268BR

Associate, Senior Clinical Data Manager

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