<職務の目的>
当局申請のため、臨床試験データ(データベース・症例一覧表・解析帳票)の品質を保証する
<職務内容>
・臨床試験のデータベース、統計解析帳票の品質管理
・臨床試験のデータマネジメント、統計解析に関するPMDA書面調査対応用の各種申請資料の作成・整理
・申請準備のための、プログラムを用いたデータチェックの実施、一覧表等の作成
・CRO の業務管理
・上記業務におけるグローバルチームとの業務連携
医療機器・医薬品に関する当局申請業務のための書面調査提出資料や社内資料の作成・整理業務を行って頂きます。開発関連部門と協働しながらの業務となります。対象となる臨床試験は弊社で計画・実施したもの、買収等により他社から引き継いだものの2種類あります。
申請プロジェクトの企画段階から業務に参加して頂き、スケジュールやコストなどについて部門の立場から助言、発信を行って頂きます。データベース、プログラミングに関する理解と技術、他部門に伝達するための柔軟なコミュニケーション能力が必要となります。
当面はプログラミング関連の業務が主なものですが、将来はクリニカルバイオメトリクス部を率いて活躍して頂ける人材を募集します。
<応募資格>
英語:会議用の資料作成とプレゼンができる程度
スキル:SAS、R、またはほかの言語(応相談)によるプログラミング経験(5年以上)
CDISC、EDC等の電子的成果物を扱うPMDAへの申請業務経験(5年以上)
電子的成果物に関するPMDAの規制・ガイドラインの知識
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
Find Jobs for Employees
Find Jobs for Contingent Worker
-
Tokyo Alcon ¥5,000,000 - ¥10,000,000 per year臨床試験のデータ管理部門シニアアソシエイトの仕事は、臨床試験データの品質を保証するために、データベース、統計解析帳票の品質管理、データマネジメント、統計解析に関するPMDA書面調査対応用の各種申請資料の作成・整理、プログラムを用いたデータチェックの実施、一覧表等の作成、CRO の業務管理、グローバルチームとの業務連携を行うことです。 ...
-
Tokyo Alcon Full time¥7,000,000 - ¥11,000,000 per year私,ヲg4uff31f · · 0,1,234 · ...
-
Tokyo Alcon Research ¥3,000,000 - ¥7,000,000 per year臨床試験データの品質を保証し、PMDAへの申請業務を行う。 · 臨床試験のデータベース、統計解析帳票の品質管理 · CRO の業務管理 · ...
-
Tokyo Alcon ¥900,000 - ¥1,200,000 per year臨床試験データ管理の専門家として、データベースの品質管理、統計解析帳票の品質管理、PMDA書面調査対応用の各種申請資料の作成・整理、プログラムを用いたデータチェックの実施、一覧表等の作成、CROの業務管理、グローバルチームとの業務連携を行います。 ...
-
Tokyo MSDContribute to various experiences in development projects through expertise acquisition, scientific level improvement, logical thinking reinforcement, etc. · We aim to create new value as Oncology Clinical Science One Team by combining diverse wisdom and experience. · This role p ...
-
Tokyo Medtronic Full timeClinical Research Specialist role involves leading clinical trials planning and execution in collaboration with various departments. The specialist will be responsible for creating or reviewing related documents such as SOPs and managing trial milestones. · ...
-
Minato Novartis ¥4,000,000 - ¥6,000,000 per yearClinical Research Associate monitors patient data and research-related information at clinical research sites and clinical trials. Investigator provides input to data validation plans in accordance with research protocols, regulatory requirements, and good clinical practices. Pro ...
-
PK specialist
2ヶ月前
Tokyo SERVIER MONDE Full time¥1,000,000 - ¥1,300,000 per yearLeveraging the latest insights in pharmacokinetics (PK) and pharmacodynamics (PD), we apply advanced kinetic analysis to drive efficient drug development, regulatory registration and maximize compound value. · ...
-
PK specialist
2週間前
Tokyo ServierWe are seeking an experienced PK specialist to join our team in Japan. As a PK specialist, you will play a critical role in driving efficient drug development and regulatory registration. · ...
-
Minato GSKThis position is responsible for conducting scientific evaluations of drug characteristics from a non-clinical perspective, developing domestic development strategies, and preparing materials to meet regulatory requirements. It also contributes to the implementation and approval ...
-
Tokyo ICON plc ¥5,000,000 - ¥9,000,000 per yearWe are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc.In this critical role, you will be responsible for overseeing the planning, execution, · and successful completion of clinical trials, ensuring adherence to timelines, · budgets,and ...
-
PK specialist
2ヶ月前
Tokyo Servier ¥900,000 - ¥1,200,000 per yearLeveraging advanced kinetic analysis to drive efficient drug development · and maximize compound value. · ...
-
Chiyoda MSD Full time¥5,000,000 - ¥10,000,000 per yearWe are seeking a highly skilled and experienced R&D Oncology Clinical Science Clinical Research Sr. Scientist to join our team. The successful candidate will be responsible for developing and implementing clinical research strategies, collaborating with cross-functional teams, an ...
-
Chiyoda MSD Full time¥5,000,000 - ¥10,000,000 per yearWe are seeking a Senior Clinical Scientist to join our Oncology Clinical Science team. The successful candidate will be responsible for leading clinical trials and developing strategies for the development of new oncology drugs. The role requires strong communication and collabor ...
-
Akasaka, Tokyo GSKNonclinica Project Specialist job description and requirements in Japan. · ...
-
Tokyo myGwork - LGBTQ+ Business Community+Job summary · This job involves working on statistical tasks related to vaccine projects, including clinical trial reports and approval materials.+ResponsibilitiesProviding statistical services for vaccine project-related activities. · Creating and managing quality control plans ...
-
Tokyo Tenth Revolution Group ¥2,000,000 - ¥2,800,000 per yearThis position plays a key part in ensuring the stable operation of business applications used across Japan.As a leader in application operations and maintenance you will collaborate with development teams business teams and global teams to maintain quality drive continuous improv ...
-
ihcra
2ヶ月前
Tokyo ICON plc ¥1,500,000 - ¥1,800,000 per yearWe are seeking an IHCRA (In-House Clinical Research Associate) to join our diverse and dynamic team. As an IHCRA at ICON, you will play a pivotal role in supporting the execution and management of clinical trials, · Various annual leave entitlements · A range of health insurance ...
-
Tokyo Galderma Full timeWe look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. · ...
-
Chuo-ku, Tokyo Johnson & Johnson MedTech ¥1,200,000 - ¥2,400,000 per yearWe believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured. · Innovative Medicine and MedTech solutions today to deliver breakthroughs of tomorrow. · ...
-
ihcra
2ヶ月前
Tokyo ICON plc ¥4,000,000 - ¥12,000,000 per yearICON is a world-leading healthcare intelligence and clinical research organization that fosters an inclusive environment driving innovation and excellence. · We're currently seeking an IHCRA (In-House Clinical Research Associate) to support the execution and management of clinica ...