Manager ,Clinical Data Management
外資医療機器メーカー
想定年収
900万円 ~ 1,200万円
勤務地
東京都
仕事内容
Responsible for clinical data management (CDM) strategy, execution, and staffing for multiple clinical trials within the trans catheter heart valve (THV) business unit within a region. Is knowledgeable regarding regulatory policies and applies this knowledge to CDM processes. Ensures CDM deliverables are of high quality and are provided in a manner to support the overall Clinical Strategy.
How you will make an impact:
• Manage a small team of clinical data management SMEs to maintain project assignments, set goals and expectations, and provide issue resolution support to direct reports.
• Plan and lead Data Management activities for multiple (multi-site and multi-cohort) projects for both clinical trials and PMS (Post Monitoring Surveillance) post commercial trials, with accountability for successful completion to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
• Develop Data Management deliverables including data management plans (DMPs), SOPs, work instructions, user training and associated documents for CDM.
• Identify and evaluate Data Management process improvements and course correction/course alignment opportunities (e.g., developing instruments to effectively identify trends in data discrepancies, identifying need for training and recommending appropriate training programs.)
• Provide direction and guidance to other team members (e.g. CRAs, PMS staff) to execute tactical Data Management initiatives
• Identify discrepancies in data and investigate and liaise with Doctors and clinicians to develop solutions to resolve issues
• Other incidental duties
募集人数
1人
応募条件
技能/経験
Education and Experience:
Bachelor's Degree in in related field , 8 years years experience in Clinical Data Management (CDM), clinical data entry, or clinical research Required andExperience working with clinical data and systems Required
What you’ll need (Required):
• Proven successful project management skills
• Proven expertise in both Microsoft Office Suite (including advanced Excel) and EDC (Electronic Data Capture) systems
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Good English skills
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive understanding of related aspects of Clinical Data Management processes and/or systems
• Strict attention to detail
•Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Represents leadership on sections of projects within a specific area interfacing with project managers and Clinical Affairs team
• Consult in project setting within specific sections of Clinical Data Management area
• Provides Clinical Data Management leadership to outsourcing partners on a task level
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
学歴
大学
職務経験
要
業界経験
要
年齢
年齢制限不問
英語力
上級以上
その他語学力
語学力詳細
ー
勤務条件
雇用形態
無期雇用
試用期間
有り(6ヶ月)
給与
年俸制
年収:900万円 ~ 1,200万円
月額基本給:60万円~85万円
賞与・インセンティブ
年1回
インセンティブ16%(業績変動賞与)
※詳細はオファーレターにてご確認ください。
昇給
有り 年1回 / 4月
勤務地
東京都
就業時間
09:00~17:30
休憩時間:1時間
残業:月20時間~
固定(定額)残業代制
残業手当
その他
固定残業時間超過分は別途支給されます。
通勤手当
交通費:全額支給(通勤交通費:定期代を支給していますが、経路は最短距離での計算です。)
休日・休暇
完全週休二日制, 土, 日, 祝日, 年末年始
年間休日:123
年間有給休暇:有給休暇は入社時から付与されます
( 入社7ヶ月目には最低10日以上 )
社会保険
雇用保険, 健康保険, 労災保険, 厚生年金
求人No.:NJB2396644
最終更新日:2026/7/17
