メディカル・バイオ - メディカルデータマネジメント

Role OverviewThe Data Management Expert serves as a key subject matter expert in data management activities, particularly in early clinical development phases. Responsibilities include vendor management, mentoring staff, leading working groups, and presenting best practices at industry events.

Key Responsibilities:
Data Management ExpertiseAct as the primary expert on data management processes in early clinical development.Mentor junior staff and train team members.Lead expert working groups and present at industry meetings.Participate in vendor selection, management, and due diligence assessments.

PDM/EPDM Tasks
Govern the use of data management standards across studies.Develop and maintain Medical Standards and data structure standards.Ensure adherence to Data Management Best Practices and SOP compliance.Oversee outsourcing activities, including budget input and vendor management.Advise on resource planning based on clinical activity forecasts.Facilitate smooth project transitions between research and development phases.Support data-driven processes across interfacing business functions.

SDM Tasks
Serve as Study Data Manager for internal and outsourced studies.Ensure accountability for CDM deliverables from protocol creation to data release.Manage risk identification and mitigation in data management plans.Document all activities according to SOPs and lead quality control efforts.Develop study-specific eCRFs and data consistency checks.Prepare and implement standard plans for data management governance.Engage in ongoing data review and reconciliation activities.

Additional Responsibilities
Establish data management best practices for research activities.Demonstrate Dynamic Shared Ownership and independent project management.Embrace and integrate new technologies to improve data management efficiency.

Compliance
Ensure compliance with SOPs, GCP, and ICH guidelines.Maintain accurate and timely documentation for all projects.

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

【学歴・資格】
- Bachelor’s degree (or equivalent/higher), preferably in the fields of Natural Sciences, Life Sciences, Informatics, Medical Documentation or related subject
【経験・職務に必要な能力】
■Experience: 2-5 years in study/project-level data management, with at least 2 years as a Study Data Manager or equivalent in a scientific, data-driven role within medical research.
■Experience in pharmaceutical companies or CROs is preferred.
■Knowledge: Strong understanding of the drug development process and relevant research methodologies.
■Technical Proficiency: Familiarity with data management methodologies and technologies, including Electronic Data Capture, data warehousing, and SAS.
■Regulatory Knowledge: Understanding of ICH, GCP, European Clinical Trials Directive, and privacy regulations (e.g., HIPAA).- Good understanding of the drug development process, understanding of relevant research processes.
■Detail-Oriented: Ability to execute data management activities independently with precision.
■Leadership: Capable of leading a Clinical Data Management (CDM) team and contributing to project-level activities.
■Collaboration: Strong organizational skills with the ability to work effectively in a global environment and collaborate with minimal supervision.
■Customer Focus: Demonstrates a commitment to customer satisfaction and drives results.
■Planning & Alignment: Effectively plans and aligns project activities.
■Interpersonal Skills: Instills trust and manages complexity in team dynamics.

【理想人物像】
■Must have experience as a study data manager for at least 2 to 5 years
■Someone with experience working with global teams would be preferrable
■Fluency in Japanese and English is required

■職種未経験者：不可